This was an open label, multicentric, non-comparative, single arm prospective post marketing surveillance (PMS) study to evaluate the safety and tolerability of Mucinex™ (GGE, 600 mg ER bi-layer tablets, taken as 1200 mg BID dose) in the treatment of otherwise healthy patients with symptoms of cough, thickened mucus and chest congestion due to URTI. Symptomatic patients who visited the outpatient department of hospitals and clinics or general physicians and had agreed to participate in this study were screened and enrolled into the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
552
2 tablets of Mucinex™ (GGE, 600 mg extended-release bi-layer tablets)
Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)
Treatment Emergent Adverse Event (TEAE) are events occurring after the first dose of study medication. Frequency of AE(s) - the total Number of Events Type of AE(s) - Serious TEAE and Non serious TEAE
Time frame: Up to Day 9
Number of Subjects Affected With Adverse Events
Proportion of patients with AE(s) - Number of Subjects affected with Events
Time frame: Up to Day 9
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
Intensity determined. Mild = AE did not limit usual activities; subject may have experienced slight discomfort. Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort. Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain. Relationship to Investigational Medicinal Products (IMP) Unassessable/Unclassified = Insufficient information to be able to make an assessment Conditional/ Unclassified = Insufficient information to make an assessment at present Unrelated = No possibility that the AE was caused by the IMP Unlikely = Slight, but remote, chance that the AE was caused by the IMP, but the balance of judgment was that it was most likely not due to the IMP. Possible = Reasonable suspicion that the AE was caused by the IMP Probable = Most likely that the AE was caused by the IMP Certain = AE was definitely caused by the IMP
Time frame: Up to Day 9
Overall Assessment of the Study Medication by End of Study Patient Questionnaire
End of Study Patient Questionnaire is a questionnaire provided to the patients for overall assessment of the study medication at the end of study visit. Satisfied(stfd) Dissatisfied(Dstfd)
Time frame: Up to Day 9
Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
End of Study Investigator Questionnaire is a questionnaire provided at the end of study visit to the investigator (or sub-investigator as applicable) for overall assessment of the study medication across all patients treated by them. End of study investigator questionnaire was collected from 9 investigators. Mostly Satisfied(MS) Satisfied(Stfd) Very Satisfied(VS) Chest Congestion(CC) Chesty Cough(CCO) Difference(Diff) Between(b/w) Somewhat Agree(SA) Strongly Agree(StA) Upper respiratory tract infection(URTI) Optimal dosage(Opt dos) Cough preparations Available(CPA)
Time frame: Up to Day 9
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