Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED) (NCT NCT00491764)
NCT ID: NCT00491764
Last Updated: 2017-04-07
Results Overview
Complete cure is defined as negative mycology (negative culture and KOH \[potassium hydroxide\]) and 0% nail involvement (defined as absence of onycholysis and subungual hyperkeratosis).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
218 participants
Primary outcome timeframe
Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48
Results posted on
2017-04-07
Participant Flow
A total of 690 subjects were enrolled in the study and screened for eligibility. A total of 472 were screen-failures, leaving 218 subjects randomized to treatment.
Participant milestones
| Measure |
Posaconazole 100 mg QD for 24 Weeks
Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
|
Posaconazole 200 mg QD for 24 Weeks.
Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
|
Posaconazole 400 mg QD for 24 Weeks.
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
|
Posaconazole 400 mg QD for 12 Weeks.
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
|
Terbinafine 250 mg QD for 12 Weeks.
Terbinafine 250 mg QD for 12 weeks.
|
Placebo for 24 Weeks
Placebo for 24 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
37
|
37
|
36
|
36
|
36
|
36
|
|
Overall Study
COMPLETED
|
32
|
30
|
28
|
28
|
33
|
27
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
8
|
8
|
3
|
9
|
Reasons for withdrawal
| Measure |
Posaconazole 100 mg QD for 24 Weeks
Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
|
Posaconazole 200 mg QD for 24 Weeks.
Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
|
Posaconazole 400 mg QD for 24 Weeks.
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
|
Posaconazole 400 mg QD for 12 Weeks.
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
|
Terbinafine 250 mg QD for 12 Weeks.
Terbinafine 250 mg QD for 12 weeks.
|
Placebo for 24 Weeks
Placebo for 24 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
4
|
4
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
1
|
2
|
2
|
4
|
|
Overall Study
Non Compliance with the Protocol
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Did not Meet Protocol Eligibility
|
0
|
1
|
1
|
0
|
1
|
1
|
|
Overall Study
Administrative
|
1
|
0
|
2
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Posaconazole 100 mg QD for 24 Weeks
n=37 Participants
Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
|
Posaconazole 200 mg QD for 24 Weeks.
n=37 Participants
Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
|
Posaconazole 400 mg QD for 24 Weeks.
n=36 Participants
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
|
Posaconazole 400 mg QD for 12 Weeks.
n=36 Participants
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
|
Terbinafine 250 mg QD for 12 Weeks.
n=36 Participants
Terbinafine 250 mg QD for 12 weeks.
|
Placebo for 24 Weeks
n=36 Participants
Placebo for 24 weeks.
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
49.9 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
50.1 years
STANDARD_DEVIATION 12.2 • n=21 Participants
|
48.4 years
STANDARD_DEVIATION 14.8 • n=8 Participants
|
50.8 years
STANDARD_DEVIATION 12.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
45 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
173 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48Population: This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication
Complete cure is defined as negative mycology (negative culture and KOH \[potassium hydroxide\]) and 0% nail involvement (defined as absence of onycholysis and subungual hyperkeratosis).
Outcome measures
| Measure |
Posaconazole 100 mg QD for 24 Weeks
n=35 Participants
Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
|
Posaconazole 200 mg QD for 24 Weeks.
n=37 Participants
Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
|
Posaconazole 400 mg QD for 24 Weeks.
n=33 Participants
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
|
Posaconazole 400 mg QD for 12 Weeks.
n=35 Participants
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
|
Terbinafine 250 mg QD for 12 Weeks.
n=35 Participants
Terbinafine 250 mg QD for 12 weeks.
|
Placebo for 24 Weeks
n=32 Participants
Placebo for 24 weeks.
|
|---|---|---|---|---|---|---|
|
Complete Cure of Onychomycosis at Week 48.
|
8 Participants
|
20 Participants
|
15 Participants
|
7 Participants
|
13 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48Population: This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication
Effective treatment is defined as negative mycology (negative culture and KOH) and either 0% nail involvement or \>5 mm growth of unaffected nail
Outcome measures
| Measure |
Posaconazole 100 mg QD for 24 Weeks
n=35 Participants
Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
|
Posaconazole 200 mg QD for 24 Weeks.
n=37 Participants
Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
|
Posaconazole 400 mg QD for 24 Weeks.
n=33 Participants
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
|
Posaconazole 400 mg QD for 12 Weeks.
n=35 Participants
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
|
Terbinafine 250 mg QD for 12 Weeks.
n=35 Participants
Terbinafine 250 mg QD for 12 weeks.
|
Placebo for 24 Weeks
n=32 Participants
Placebo for 24 weeks.
|
|---|---|---|---|---|---|---|
|
Effective Treatment of Onychomycosis at Week 48.
|
9 Participants
|
24 Participants
|
16 Participants
|
11 Participants
|
19 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48Population: This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication
Treatment success was defined as negative mycology (negative culture and negative KOH) and =\<10% nail involvement.
Outcome measures
| Measure |
Posaconazole 100 mg QD for 24 Weeks
n=35 Participants
Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
|
Posaconazole 200 mg QD for 24 Weeks.
n=37 Participants
Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
|
Posaconazole 400 mg QD for 24 Weeks.
n=33 Participants
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
|
Posaconazole 400 mg QD for 12 Weeks.
n=35 Participants
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
|
Terbinafine 250 mg QD for 12 Weeks.
n=35 Participants
Terbinafine 250 mg QD for 12 weeks.
|
Placebo for 24 Weeks
n=32 Participants
Placebo for 24 weeks.
|
|---|---|---|---|---|---|---|
|
Treatment Success of Onychomycosis at Week 48
|
11 Participants
|
24 Participants
|
22 Participants
|
11 Participants
|
20 Participants
|
0 Participants
|
Adverse Events
Posaconazole 100 mg QD for 24 Weeks
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Posaconazole 200 mg QD for 24 Weeks
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Posaconazole 400 mg QD for 24 Weeks
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Posaconazole 400 mg QD for 12 Weeks
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Terbinafine 250 mg QD for 12 Weeks
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo for 24 Weeks
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Posaconazole 100 mg QD for 24 Weeks
n=36 participants at risk
Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks
|
Posaconazole 200 mg QD for 24 Weeks
n=37 participants at risk
Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks
|
Posaconazole 400 mg QD for 24 Weeks
n=36 participants at risk
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks
|
Posaconazole 400 mg QD for 12 Weeks
n=36 participants at risk
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks
|
Terbinafine 250 mg QD for 12 Weeks
n=36 participants at risk
Terbinafine 250 mg QD for 12 weeks
|
Placebo for 24 Weeks
n=35 participants at risk
Placebo for 24 weeks
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.9%
1/35 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.9%
1/35 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.9%
1/35 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.9%
1/35 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
Other adverse events
| Measure |
Posaconazole 100 mg QD for 24 Weeks
n=36 participants at risk
Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks
|
Posaconazole 200 mg QD for 24 Weeks
n=37 participants at risk
Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks
|
Posaconazole 400 mg QD for 24 Weeks
n=36 participants at risk
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks
|
Posaconazole 400 mg QD for 12 Weeks
n=36 participants at risk
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks
|
Terbinafine 250 mg QD for 12 Weeks
n=36 participants at risk
Terbinafine 250 mg QD for 12 weeks
|
Placebo for 24 Weeks
n=35 participants at risk
Placebo for 24 weeks
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.4%
2/37 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
11.1%
4/36 • Number of events 7
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.7%
2/35 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.9%
1/35 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Gastrointestinal disorders
FLATULENCE
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Gastrointestinal disorders
HYPERCHLORHYDRIA
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Gastrointestinal disorders
NAUSEA
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
8.1%
3/37 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.6%
2/36 • Number of events 6
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.7%
2/35 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Gastrointestinal disorders
VOMITING
|
2.8%
1/36 • Number of events 6
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.4%
2/37 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 4
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
General disorders
FATIGUE
|
8.3%
3/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.9%
1/35 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
General disorders
PAIN
|
8.3%
3/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.7%
2/35 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Immune system disorders
SEASONAL ALLERGY
|
5.6%
2/36 • Number of events 6
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.4%
2/37 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.9%
1/35 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
8.3%
3/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.7%
2/35 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Infections and infestations
INFLUENZA
|
8.3%
3/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
8.3%
3/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Infections and infestations
LARYNGITIS
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Infections and infestations
NASOPHARYNGITIS
|
11.1%
4/36 • Number of events 6
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
8.1%
3/37 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
16.7%
6/36 • Number of events 7
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.6%
2/36 • Number of events 4
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
8.3%
3/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
17.1%
6/35 • Number of events 6
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Infections and infestations
SINUSITIS
|
5.6%
2/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.7%
2/35 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Infections and infestations
TINEA PEDIS
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
8.6%
3/35 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
13.9%
5/36 • Number of events 5
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
8.3%
3/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
16.7%
6/36 • Number of events 7
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
13.9%
5/36 • Number of events 5
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.9%
1/35 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.6%
2/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
8.3%
3/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
2.8%
1/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.4%
2/37 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.9%
1/35 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Nervous system disorders
AGEUSIA
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
13.5%
5/37 • Number of events 5
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Nervous system disorders
HEADACHE
|
11.1%
4/36 • Number of events 4
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 13
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
8.3%
3/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
8.3%
3/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
8.3%
3/36 • Number of events 4
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.7%
1/37 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
8.3%
3/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
5.6%
2/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.4%
2/37 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
11.1%
4/36 • Number of events 5
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.6%
2/36 • Number of events 3
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.9%
1/35 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
11.1%
4/36 • Number of events 5
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Skin and subcutaneous tissue disorders
ONYCHALGIA
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/37
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/36
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
5.6%
2/36 • Number of events 2
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
2.8%
1/36 • Number of events 1
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
0.00%
0/35
Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PI must provide to sponsor 45 days prior to submission for publication/presentation, review copies of content to be presented that contains any results of the study. The sponsor has the right to review/comment with regard to proprietary information, accuracy, and fair balance. If disagreements arise concerning appropriateness of content to be presented, investigator must meet with sponsor prior to submission for publication to make good faith efforts to discuss/resolve any issues/disagreement.
- Publication restrictions are in place
Restriction type: OTHER