This is a Phase IV randomized, double-blinded, placebo-controlled study in 1000 individuals aged 18 years or older, with community acquired pneumonia (CAP) who meet all eligibility criteria in endemic regions. This study is designed to provide data on the effectiveness of early antifungal treatment (Fluconazole, 400 mg/day) for coccidioidomycosis pneumonia (also referred to as Valley Fever (VF) Pneumonia or acute onset valley fever) vs. placebo in subjects with coccidioidomycosis pneumonia. Patients who are prescribed antibacterials by their health care provider for acute CAP will be randomized to receive either placebo or 400 mg/day of fluconazole for 42 days. The primary objective is to assess the clinical response of early empiric antifungal therapy with fluconazole at Day 22 in subjects with coccidioidomycosis pneumonia and are compliant with the study intervention.
This is a Phase IV randomized, double-blinded, placebo-controlled study in 1000 individuals, aged 18 years or older, with community acquired pneumonia (CAP) who meet all eligibility criteria in endemic regions. This study is designed to provide data on the effectiveness of early antifungal treatment (Fluconazole, 400 mg/day) for coccidioidomycosis pneumonia (also referred to as Valley Fever (VF) Pneumonia or acute onset valley fever) vs. placebo in subjects with coccidioidomycosis pneumonia. Patients who are prescribed antibacterials by their health care provider for acute CAP will be randomized to receive either placebo or 400 mg/day of fluconazole for 42 days. Blood work for serologic determination of coccidioidomycosis infection will be drawn at the time of randomization (Day 1), and again on Days, 22, 29, and 43. On Day 43, subjects will be informed of their treatment assignment and results of serologic testing from Days 1, 22 and 29. At Day 43, those subjects who did not meet the protocol defined case definition for CAP caused by acute coccidioidomycosis and who did not receive fluconazole will be dismissed from the study and referred to a health care provider with the results of their serology testing and their treatment assignment. All subjects who received fluconazole will be evaluated for safety follow up at Day 49. At Day 49, those subjects who did not meet the protocol defined case definition for CAP caused by acute coccidioidomycosis will be dismissed from the study and referred to a health care provider with the results of their serology testing and their treatment assignment. Subjects who did meet the protocol defined case definition for CAP caused by acute coccidioidomycosis infection will be referred to a healthcare provider with the results of their serology testing and their treatment assignment for further treatment as indicated and will be contacted by telephone on Days 90 and 180. The study duration will be approximately 72 months, and the subject participant duration will be from 42 days to approximately 6 months. The primary objective is to assess the clinical response of early empiric antifungal therapy with fluconazole at Day 22 in subjects with coccidioidomycosis pneumonia who are adherent to the study intervention. The secondary objectives are: 1) To assess the clinical response of early empiric antifungal therapy with fluconazole at Day 22 in subjects with coccidioidomycosis pneumonia regardless of adherence with the study intervention; 2) To assess the clinical response of early empiric antifungal therapy with fluconazole at Day 43 in subjects with coccidioidomycosis pneumonia regardless of adherence with the study intervention; 3) To compare the clinical response and its individual components over time, by treatment group, in subjects with coccidioidomycosis pneumonia; 4) To assess the impact of early empiric antifungal therapy with fluconazole on days lost from work or school and responses to the SF-12v2 and PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in subjects with coccidioidomycosis pneumonia; 5) To assess the effect of early empiric antifungal therapy with fluconazole through Day 43 in subjects with coccidioidomycosis pneumonia on all-cause mortality by treatment group; and 6) To assess whether early empiric antifungal therapy with fluconazole at Day 22 is non-inferior to placebo as defined by clinical response at Day 22 in all randomized subjects, regardless of coccidioidomycosis pneumonia status or adherence with study intervention, with baseline and follow-up FLEET-CAP scores.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Fluconazole is a synthetic triazole antifungal agent. It will be supplied as 200 mg over encapsulated tablets. Each gelatin capsule will contain two-100 mg fluconazole tablets and microcrystalline cellulose for overfill.
Placebo will be supplied as matching gelatin capsules containing microcrystalline cellulose only. Capsules are the same size, weight, and color as capsules containing fluconazole tablets.
Banner - University Medical Center Advanced Lung Disease Clinic - Phoenix
Phoenix, Arizona, United States
St Josephs Hospital and Medical Center - Center for Liver Disease and Transplantation - Phoenix
Phoenix, Arizona, United States
Mayo Clinic, Phoenix - Infectious Diseases
Phoenix, Arizona, United States
Mayo Clinic, Scottsdale - Infectious Diseases
Scottsdale, Arizona, United States
The University of Arizona - Banner University Medical Center Tucson Campus - Tucson
Tucson, Arizona, United States
Kaiser Permanente Chester Avenue Medical Offices - Pulmonology
Bakersfield, California, United States
Kern Medical Center - Medicine
Bakersfield, California, United States
UCSF Fresno Center for Medical Education and Research - Clinical Research Center
Fresno, California, United States
Kaiser Permanente Antelope Valley Medical Offices - Infectious Diseases
Lancaster, California, United States
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci-positive Per-protocol Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.
Time frame: Visit 2 - Visit 4 (Day 20-46)
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.
Time frame: Visit 2 - Visit 4 (Day 20-46)
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.
Time frame: Visit 2 - Visit 4 (Day 20-46)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
Number of the Days of School or Work Missed Due to Illness in the ITT Population
Number of the days of school or work missed due to illness by participant self-report
Time frame: Visit 1 (Day 1) through Visit 4 (Day 42-46)
Number of the Days of School or Work Missed Due to Illness in the Cocci Positive mITT Population
Number of the days of school or work missed due to illness by participant self-report
Time frame: Visit 1 (Day 1) through Visit 4 (Day 42-46)
Number of the Days of School or Work Missed Due to Illness in the All Randomized PP Population
Number of the days of school or work missed due to illness by participant self-report
Time frame: Visit 1 (Day 1) through Visit 4 (Day 42-46)
Number of the Days of School or Work Missed Due to Illness in the Cocci Positive PP Population
Number of the days of school or work missed due to illness by participant self-report
Time frame: Visit 1 (Day 1) through Visit 4 (Day 42-46)
Number of the Days of School or Work Missed Due to Illness in the All Randomized mITT Population
Number of the days of school or work missed due to illness by participant self-report
Time frame: Visit 1 (Day 1) through Visit 4 (Day 42-46)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 2 (Day 20-23)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 3 (Day 27-30)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 4 (Day 42-46)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 6 (Day 83-97)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 7 (Day 173-187)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 2 (Day 20-23)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 3 (Day 27-30)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 4 (Day 42-46)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 6 (Day 83-97)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 7 (Day 173-187)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 2 (Day 20-23)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 3 (Day 27-30)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 4 (Day 42-46)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 6 (Day 83-97)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 7 (Day 173-187)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 2 (Day 20-23)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 3 (Day 27-30)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 4 (Day 42-46)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 6 (Day 83-97)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 7 (Day 173-187)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 2 (Day 20-23)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 3 (Day 27-30)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 4 (Day 42-46)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 6 (Day 83-97)
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as "Never", "Rarely", "Sometimes", "Usually", or "Always" with an "Always" response indicating the most trouble participating in social roles and activities.
Time frame: Visit 7 (Day 173-187)
Incidence Rate of All-cause Mortality
Mortality information was obtained through medical records or next of kin.
Time frame: Day 1 through Day 43
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants, Regardless of Coccidioidomycosis Status or Adherence to Study Drug
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
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