Trial Outcomes & Findings for Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail. (NCT NCT00356915)

NCT ID: NCT00356915

Last Updated: 2017-02-09

Results Overview

This study was designed to evaluate the superiority of itraconazole tablets to placebo tablets. Clinical Cure was defined as an IGA score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) exam and a negative culture for dermatophytes of the target toenail.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1381 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2017-02-09

Participant Flow

Subjects were recruited from clinics in the US, Canada, South America, Ecuador, Dominican Republic, Panama, and Honduras.

Subjects were screened prior to randomization and had to have a positive result from a mycological culture of their toe nail (ie, culture that was positive for dermatophytes). If the culture was negative, they were not randomized to receive treatment and were discontinued from the study.

Participant milestones

Measure	Itraconazole Tablets Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.	Itraconazole Capsules Itraconazole 100 mg capsules	Placebo Tablets Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
Overall Study STARTED	593	590	198
Overall Study COMPLETED	517	496	156
Overall Study NOT COMPLETED	76	94	42

Reasons for withdrawal

Measure	Itraconazole Tablets Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.	Itraconazole Capsules Itraconazole 100 mg capsules	Placebo Tablets Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
Overall Study Non compliance	1	2	1
Overall Study Protocol Violation	2	3	2
Overall Study Withdrawal by Subject	14	14	10
Overall Study Lack of Efficacy	0	0	3
Overall Study Lost to Follow-up	27	34	14
Overall Study Administrative Decision	0	0	1
Overall Study Physician Decision	0	2	0
Overall Study Adverse Event	21	31	8
Overall Study Miscellaneous reasons	11	8	3

Baseline Characteristics

Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.

Baseline characteristics by cohort

Measure	Itraconazole Tablets n=593 Participants Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.	Itraconazole Capsules n=590 Participants Itraconazole 100 mg capsules	Placebo Tablets n=198 Participants Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).	Total n=1381 Participants Total of all reporting groups
Age, Continuous	47.1 years STANDARD_DEVIATION 11.86 • n=93 Participants	47 years STANDARD_DEVIATION 12.67 • n=4 Participants	49.2 years STANDARD_DEVIATION 11.12 • n=27 Participants	47.4 years STANDARD_DEVIATION 12.13 • n=483 Participants
Gender Female	441 Participants n=93 Participants	440 Participants n=4 Participants	153 Participants n=27 Participants	1034 Participants n=483 Participants
Gender Male	152 Participants n=93 Participants	150 Participants n=4 Participants	45 Participants n=27 Participants	347 Participants n=483 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	7 Participants n=93 Participants	7 Participants n=4 Participants	4 Participants n=27 Participants	18 Participants n=483 Participants
Race/Ethnicity, Customized Asian	5 Participants n=93 Participants	4 Participants n=4 Participants	2 Participants n=27 Participants	11 Participants n=483 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race/Ethnicity, Customized Black or African American	48 Participants n=93 Participants	48 Participants n=4 Participants	18 Participants n=27 Participants	114 Participants n=483 Participants
Race/Ethnicity, Customized White	512 Participants n=93 Participants	493 Participants n=4 Participants	169 Participants n=27 Participants	1174 Participants n=483 Participants
Race/Ethnicity, Customized Unknown or Not Reported	25 Participants n=93 Participants	41 Participants n=4 Participants	7 Participants n=27 Participants	73 Participants n=483 Participants
Region of Enrollment Panama	9 participants n=93 Participants	9 participants n=4 Participants	3 participants n=27 Participants	21 participants n=483 Participants
Region of Enrollment United States	527 participants n=93 Participants	523 participants n=4 Participants	176 participants n=27 Participants	1226 participants n=483 Participants
Region of Enrollment Canada	23 participants n=93 Participants	21 participants n=4 Participants	8 participants n=27 Participants	52 participants n=483 Participants
Region of Enrollment Ecuador	6 participants n=93 Participants	8 participants n=4 Participants	3 participants n=27 Participants	17 participants n=483 Participants
Region of Enrollment Honduras	9 participants n=93 Participants	9 participants n=4 Participants	3 participants n=27 Participants	21 participants n=483 Participants
Region of Enrollment Dominican Republic	7 participants n=93 Participants	9 participants n=4 Participants	2 participants n=27 Participants	18 participants n=483 Participants
Region of Enrollment South Africa	12 participants n=93 Participants	11 participants n=4 Participants	3 participants n=27 Participants	26 participants n=483 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Intent to treat (ITT).

This study was designed to evaluate the superiority of itraconazole tablets to placebo tablets.

Clinical Cure was defined as an IGA score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) exam and a negative culture for dermatophytes of the target toenail.

Outcome measures

Measure	Itraconazole Tablets n=593 Participants Itraconazole 200mg tablets	Placebo Tablets n=198 Participants	Placebo Tablets Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
Clinical and Mycological Cure of Target Toenail	22.3 Percentage of participants	1 Percentage of participants	—

PRIMARY outcome

Timeframe: 12 months

Population: Intent to treat (ITT).

The primary efficacy endpoint was Compete Cure (consisting of a Clinical Cure and a Mycological Cure) at week 52. In this study, Clinical Cure was defined as an Investigator's Global Assessment (IGA) score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) examination and a negative culture outcome for dermatophytes of the target toenail. The efficacy analyses were conducted to demonstrate the non-inferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsule.

Outcome measures

Measure	Itraconazole Tablets n=593 Participants Itraconazole 200mg tablets	Placebo Tablets n=590 Participants	Placebo Tablets n=198 Participants Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules	22.3 Percentage of participants	21.7 Percentage of participants	1.0 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52.

The Investigator's Global Assessment (IGA) assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement.

0 = Clinical Cure: No evidence of onychomycosis.

1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis.

Outcome measures

Measure	Itraconazole Tablets n=593 Participants Itraconazole 200mg tablets	Placebo Tablets n=590 Participants	Placebo Tablets Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
Clinical Improvement of the Target Toenail	33.7 percentage of participants	29.3 percentage of participants	—

SECONDARY outcome

Timeframe: 12 months

Population: Intent to treat (ITT)

Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52.

The Investigator's Global Assessment(IGA)assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement.

0 = Clinical Cure: No evidence of onychomycosis.

1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis.

Outcome measures

Measure	Itraconazole Tablets n=593 Participants Itraconazole 200mg tablets	Placebo Tablets n=198 Participants	Placebo Tablets Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
Clinical Improvement Compared to Placebo	33.7 percentage of participants	2 percentage of participants	—

Adverse Events

Itraconazole Tablets - Treatment Period

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Itraconazole Capsules

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo Tablets

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Itraconazole Tablets - Follow-up Period

Serious events: 10 serious events

Other events: 19 other events

Deaths: 0 deaths

Itraconazole Capsules - Follow-up Period

Serious events: 9 serious events

Other events: 36 other events

Deaths: 0 deaths

Placebo Tablets - Follow-up Period

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Itraconazole Tablets - Treatment Period n=582 participants at risk Itraconazole 200mg tablets Adverse events that occurred during the Treatment Period are reported here.	Itraconazole Capsules n=581 participants at risk Itraconazole 100mg capsules Adverse events that occurred during the Treatment Period are reported here.	Placebo Tablets n=191 participants at risk Adverse events that occurred during the Treatment Period are reported here.	Itraconazole Tablets - Follow-up Period n=535 participants at risk Adverse events that occurred during the follow-up (no treatment) period are reported here.	Itraconazole Capsules - Follow-up Period n=515 participants at risk Adverse events that occurred during the follow-up (no treatment) period are reported here.	Placebo Tablets - Follow-up Period n=168 participants at risk Adverse events that occurred during the follow-up (no treatment) period are reported here.
Blood and lymphatic system disorders Anemia	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/535 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/515 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Cardiac disorders Angina Unstable	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/535 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/515 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Infections and infestations Appendicitis	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/535 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/515 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/535 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/515 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Renal and urinary disorders Calculus ureteric	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/535 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/515 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Nervous system disorders Carteroid artery aneurysm	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/535 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/515 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Nervous system disorders Cerebrovascular accident	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/535 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/515 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Hepatobiliary disorders Cholelithiasis	0.17% 1/582 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/535 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/515 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Cardiac disorders Coronary artery disease	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/535 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/515 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Cardiac disorders Cardiac failure congestive	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/535 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/515 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Infections and infestations Diverticulitis	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.52% 1/191 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/535 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/515 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/535 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/515 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblatoma multiforme	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/535 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/515 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Injury, poisoning and procedural complications Jaw Fracture	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/535 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/515 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/535 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/515 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/535 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/515 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.60% 1/168 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Cardiac disorders Myocardial infarction	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.17% 1/581 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/535 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/515 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Cardiac disorders Myocardial ischemia	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/535 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/515 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.17% 1/581 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/535 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/515 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cenll lung caner stage IV	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/535 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/515 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Gastrointestinal disorders Pancreatitis	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.52% 1/191 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/535 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/515 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/535 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/515 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.17% 1/582 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/535 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/515 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid gland cancer	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/535 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/515 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/582 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/581 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/191 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.19% 1/535 • Number of events 1 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/515 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	0.00% 0/168 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.

Other adverse events

Measure	Itraconazole Tablets - Treatment Period n=582 participants at risk Itraconazole 200mg tablets Adverse events that occurred during the Treatment Period are reported here.	Itraconazole Capsules n=581 participants at risk Itraconazole 100mg capsules Adverse events that occurred during the Treatment Period are reported here.	Placebo Tablets n=191 participants at risk Adverse events that occurred during the Treatment Period are reported here.	Itraconazole Tablets - Follow-up Period n=535 participants at risk Adverse events that occurred during the follow-up (no treatment) period are reported here.	Itraconazole Capsules - Follow-up Period n=515 participants at risk Adverse events that occurred during the follow-up (no treatment) period are reported here.	Placebo Tablets - Follow-up Period n=168 participants at risk Adverse events that occurred during the follow-up (no treatment) period are reported here.
Ear and labyrinth disorders Hypoacusis	3.3% 19/582 • Number of events 19 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	2.8% 16/581 • Number of events 16 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	3.1% 6/191 • Number of events 6 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	3.6% 19/535 • Number of events 19 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	7.0% 36/515 • Number of events 36 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.	4.8% 8/168 • Number of events 8 • AEs and SAES are reported for the 12 week treatment period. SAEs are reported for both the treatment & follow-up periods in the Additional Description section. During the follow-up period, 20 subjects (10, 9, and 1 in the itraconazole 200-mg tablet, itraconazole 100-mg capsule, and placebo tablet dosing groups, respectively) reported SAEs. Because 1 subject experienced a SAE in both periods of the study, 25 individual subjects experienced SAEs during the course of the trial.

Additional Information

GSK Response Center

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Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER