| Primary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected capsules. | Posted | | Count of Participants | | Participants | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
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| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
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| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Count of Participants | | Participants | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
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| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. |
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| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Count of Participants | | Participants | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
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| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. |
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| Secondary | 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. | The population includes all participants who took at least one dose of study medication. | Posted | | Count of Participants | | Participants | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
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| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | |
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| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Count of Participants | | Participants | | Visit 2 - Visit 4 (Day 20-46) | | | | ID | Title | Description |
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| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. |
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| Secondary | 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. | The population includes all participants who took at least one dose of study medication. | Posted | | Count of Participants | | Participants | | Visit 2 - Visit 4 (Day 20-46) | | | | ID | Title | Description |
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| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 |
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| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Count of Participants | | Participants | | Visit 2 - Visit 4 (Day 20-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. |
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| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
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| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
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| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | |
|
| Secondary | 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. | The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo |
|
| Secondary | 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. | The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo |
|
| Secondary | 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. | The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo |
|
| Secondary | 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. | The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo |
|
| Secondary | 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. | The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits. | Posted | | Mean | Inter-Quartile Range | score on a scale | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo |
|
| Secondary | 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. | The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits. | Posted | | Median | Inter-Quartile Range | score on a scale | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo |
|
| Secondary | 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 | The Intent-to-Treat (ITT) population includes all randomized participants. | Posted | | Mean | Standard Deviation | days | | Visit 1 (Day 1) through Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
| |
| Secondary | 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 | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Standard Deviation | days | | Visit 1 (Day 1) through Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
| |
| Secondary | 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 | The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits. | Posted | | Mean | Standard Deviation | days | | Visit 1 (Day 1) through Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
| |
| Secondary | 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 | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Mean | Standard Deviation | days | | Visit 1 (Day 1) through Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
| |
| Secondary | 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 | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Standard Deviation | days | | Visit 1 (Day 1) through Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
| |
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants. | Posted | | Count of Participants | | Participants | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants. | Posted | | Count of Participants | | Participants | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants. | Posted | | Count of Participants | | Participants | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants. | Posted | | Count of Participants | | Participants | | Visit 6 (Day 83-97) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants. | Posted | | Count of Participants | | Participants | | Visit 7 (Day 173-187) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Count of Participants | | Participants | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Count of Participants | | Participants | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Count of Participants | | Participants | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Count of Participants | | Participants | | Visit 6 (Day 83-97) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Count of Participants | | Participants | | Visit 7 (Day 173-187) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Count of Participants | | Participants | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Count of Participants | | Participants | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Count of Participants | | Participants | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Count of Participants | | Participants | | Visit 6 (Day 83-97) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Count of Participants | | Participants | | Visit 7 (Day 173-187) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits. | Posted | | Count of Participants | | Participants | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits. | Posted | | Count of Participants | | Participants | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits. | Posted | | Count of Participants | | Participants | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits. | Posted | | Count of Participants | | Participants | | Visit 6 (Day 83-97) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits. | Posted | | Count of Participants | | Participants | | Visit 7 (Day 173-187) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Count of Participants | | Participants | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Count of Participants | | Participants | | Visit 3 (Day 27-30) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Count of Participants | | Participants | | Visit 4 (Day 42-46) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Count of Participants | | Participants | | Visit 6 (Day 83-97) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Count of Participants | | Participants | | Visit 7 (Day 173-187) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | Incidence Rate of All-cause Mortality | Mortality information was obtained through medical records or next of kin. | The population includes all participants who took at least one dose of study medication. | Posted | | Number | | participants | | Day 1 through Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
| |
| Secondary | 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. | Intent-to-Treat (ITT) population - This efficacy analysis population includes all randomized participants. | Posted | | Count of Participants | | Participants | | Visit 2 (Day 20-23) | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point. | Posted | | Mean | Standard Deviation | score on a scale | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point. | Posted | | Mean | Standard Deviation | score on a scale | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point. | Posted | | Mean | Standard Deviation | score on a scale | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point. | Posted | | Mean | Standard Deviation | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point. | Posted | | Mean | Standard Deviation | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point. | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take >=80% of their expected pills. | Posted | | Mean | Standard Deviation | score on a scale | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take >=80% of their expected pills. | Posted | | Mean | Standard Deviation | score on a scale | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take >=80% of their expected pills. | Posted | | Mean | Standard Deviation | score on a scale | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take >=80% of their expected pills. | Posted | | Mean | Standard Deviation | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take >=80% of their expected pills. | Posted | | Mean | Standard Deviation | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take >=80% of their expected pills. | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Standard Deviation | score on a scale | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Standard Deviation | score on a scale | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Standard Deviation | score on a scale | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Standard Deviation | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Standard Deviation | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All-Randomized PP population includes all participants who took at least one dose of study medication. | Posted | | Mean | Standard Deviation | score on a scale | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All-Randomized PP population includes all participants who took at least one dose of study medication. | Posted | | Mean | Standard Deviation | score on a scale | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All-Randomized PP population includes all participants who took at least one dose of study medication. | Posted | | Mean | Standard Deviation | score on a scale | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All-Randomized PP population includes all participants who took at least one dose of study medication. | Posted | | Mean | Standard Deviation | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All-Randomized PP population includes all participants who took at least one dose of study medication. | Posted | | Mean | Standard Deviation | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All-Randomized PP population includes all participants who took at least one dose of study medication. | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Standard Deviation | score on a scale | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Standard Deviation | score on a scale | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Standard Deviation | score on a scale | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Standard Deviation | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Standard Deviation | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All-Randomized PP population includes all participants who took at least one dose of study medication. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All-Randomized PP population includes all participants who took at least one dose of study medication. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All-Randomized PP population includes all participants who took at least one dose of study medication. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All-Randomized PP population includes all participants who took at least one dose of study medication. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All-Randomized PP population includes all participants who took at least one dose of study medication. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | The All-Randomized PP population includes all participants who took at least one dose of study medication. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|
| Secondary | 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. | All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population. | Posted | | Median | Inter-Quartile Range | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Fluconazole | Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | | OG001 | Placebo | Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. |
|