Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients

Number of Participants With Defervescence Day 5 (4 Days After Initiation of Study Treatment)

Number of participants who achieved defervescence (were afebrile). Defervescence stated if all of a participants's body temperatures within 24 hours of evaluation time were \<38.0 degrees C. Defervescence was not stated and participant was discontinued from the study if participant received antipyretics (non-steroidal anti-inflammatory drugs or paracetamol).

Time frame: Day 5 (96 hours through 120 hours after start of study treatment)

Number of Participants With Defervescence Day 9 (8 Days After Initiation of Study Treatment)

Number of participants who achieved defervescence (were afebrile). Defervescence stated if all of a participant's body temperatures within 24 hours of evaluation time were \<38.0 degrees C. Defervescence was not stated and participant was discontinued from the study if participant received antipyretics (non-steroidal anti-inflammatory drugs or paracetamol).

Time frame: Day 9 (192 hours through 216 hours after start of study treatment)

Time to Continuous Defervescence

Time (in days) from start of study medication to continuous defervescence. Continuous defervescence stated if participant maintains a body temperature of \<38.0 degrees C for at least 96 hours.

Time frame: Day 2 through Day 28

Number of Participants Per Reason for Lack of Defervescence

Time frame: Day 2 through Day 28

Number of Participants That Died on or Before Day 28 (Mortality)

Number of participants that died on or before Day 28 after start of study treatment. A participant must be evaluable until Day 28 (final visit) or have died before the final visit.

Time frame: Day 2 through Day 28

Time to Negative Panfungal Polymerase Chain Reaction (PCR)

Time (in days) from start of study medication to negative panfungal PCR; assessed for participants whose most recent panfungal PCR result prior to start of study medication was positive. Defined as negative if at least 2 successive and all following panfungal PCR assessments from start of study medication until 24 hours after end of treatment are negative. Measured as first quartile of time (point in time measurement; no median or measure of dispersion calculated); median time was not estimable for deferred voriconazole treatment group.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (Yes)

Percent of positive panfungal PCR assessments during treatment phase of study in association with achievement of continuous defervescence (response=Yes). Continuous defervescence stated if participant maintains a body temperature of \<38.0 degrees C for at least 96 hours. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (No)

Percent of positive panfungal PCR assessments during treatment phase of study in association with achievement of continuous defervescence (response=No). Continuous defervescence stated if participant maintains a body temperature of \<38.0 degrees C for at least 96 hours. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Age

Percent of positive panfungal PCR assessments during treatment phase of study in association with age for participants who completed the study and have a non-missing value for percent of positive panfungal PCR.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Gender

Percent of positive panfungal PCR assessments during treatment phase of study in association with gender (Female or Male). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Primary Underlying Neoplastic Disease

Percent of positive panfungal PCR assessments during treatment phase of study in association with primary underlying neoplastic disease. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Planned Allogeneic Transplants

Percent of positive panfungal PCR assessments during treatment phase of study in association with allogeneic bone marrow transplant or allogeneic peripheral stem cell transplant (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Concomitant Fluconazole

Percent positive panfungal PCR assessments during treatment phase of study in association with use of concomitant (prophylaxis) fluconazole (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Neutrophil Count >500 uL

Percent of positive panfungal PCR assessments during treatment phase of study in association with neutrophil count \>500 uL (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With C-reactive Protein Level >1.25 Times the Upper Limit of Normal (x ULN)

Percent of positive panfungal PCR assessments during treatment phase of study in association with c-reactive protein level (measured in milligrams per liter \[mg/L\]) \>1.25 x ULN (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified

Percent of positive panfungal PCR assessments during treatment phase of study in association with fungal species (singular \[one species\]=sp; plural \[many species\]=spp) identified (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified (Aspergillus Spp=Yes)

Percent of positive panfungal PCR assessments during treatment phase of study in association with fungal species (singular \[one species\]=sp; plural \[many species\]=spp) identified (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Proven or Probable IFI (Complete Cases) Between Day 2 and Day 28

Percent of positive panfungal PCR assessments during treatment phase of study in association with proven or probable IFI (complete cases) between Day 2 and Day 28 (Yes or No). Complete case analysis: participant must be evaluable until Day 28 (final visit) or have developed a proven or probable IFI by the final visit. Participant considered evaluable until Day 28 if participant completed the study and completed an assessment of IFI at Day 28 or final visit. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence Day 5 (4 Days After Initiation of Study Treatment)

Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 5 (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 5 (96 hours through 120 hours after start of study treatment)

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (Yes) by Day 9 (8 Days After Initiation of Study Treatment)

Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 9 (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (No) by Day 9 (8 Days After Initiation of Study Treatment)

Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 9 (No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Time to Defervescence

Percent of positive panfungal PCR assessments during treatment phase of study in association with time to defervescence. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence (No)

Percent of positive panfungal PCR assessments during treatment phase of study in association with lack of continuous defervescence (No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence: Unknown Infection (Yes)

Percent of positive panfungal PCR assessments during treatment phase of study in association with lack of continuous defervescence (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Alive)

Percent of positive panfungal PCR assessments during treatment phase of study in association with mortality on or before Day 28 after start of study treatment (Alive). A participant must be evaluable until Day 28 (final visit).

Time frame: Day 2 through Day 28

Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Died)

Percent of positive panfungal PCR assessments during treatment phase of study in association with mortality on or before Day 28 after start of study treatment (Died). A participant must have died before Day 28 (final visit).

Time frame: Day 2 through Day 28

Number of Participants Assessed as Needing Further Antineoplastic Therapy as Planned

Time frame: Day 28

Number of Participants With Reasons Why Antineoplastic Therapy Not Continued as Planned

Time frame: Day 28