Trial Outcomes & Findings for Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis (NCT NCT00395629)
NCT ID: NCT00395629
Last Updated: 2011-05-30
Results Overview
Mean absolute change in serum ferritin from baseline to the end of the extension study.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
49 participants
Primary outcome timeframe
0 to 48 weeks
Results posted on
2011-05-30
Participant Flow
Participant milestones
| Measure |
Deferasirox (ICL670) 5 mg/kg/Day
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 10 mg/kg/Day
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 15 mg/kg/Day
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
|---|---|---|---|
|
Core Study
STARTED
|
11
|
15
|
23
|
|
Core Study
COMPLETED
|
10
|
11
|
16
|
|
Core Study
NOT COMPLETED
|
1
|
4
|
7
|
|
Extension Study
STARTED
|
9
|
6
|
11
|
|
Extension Study
COMPLETED
|
9
|
6
|
8
|
|
Extension Study
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Deferasirox (ICL670) 5 mg/kg/Day
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 10 mg/kg/Day
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 15 mg/kg/Day
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
|---|---|---|---|
|
Core Study
Adverse Event
|
0
|
3
|
4
|
|
Core Study
Abnormal laboratory value(s)
|
0
|
0
|
1
|
|
Core Study
Protocol Violation
|
1
|
0
|
0
|
|
Core Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Core Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Extension Study
Adverse Event
|
0
|
0
|
2
|
|
Extension Study
Administrative problems
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis
Baseline characteristics by cohort
| Measure |
Deferasirox (ICL670) 5 mg/kg/Day
n=11 Participants
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 10 mg/kg/Day
n=15 Participants
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 15 mg/kg/Day
n=23 Participants
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
Core Study
|
55.8 years
STANDARD_DEVIATION 12.78 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 10.26 • n=7 Participants
|
49.8 years
STANDARD_DEVIATION 16.41 • n=5 Participants
|
50.6 years
STANDARD_DEVIATION 14.04 • n=4 Participants
|
|
Age Continuous
Extension Study (n=9,6,11,26)
|
55.7 years
STANDARD_DEVIATION 14.23 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 10.61 • n=7 Participants
|
50.1 years
STANDARD_DEVIATION 15.88 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 14.34 • n=4 Participants
|
|
Sex/Gender, Customized
Female_Core Study
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Sex/Gender, Customized
Male_Core Study
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
13 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Sex/Gender, Customized
Female_Extension Study
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Sex/Gender, Customized
Male_Extension Study
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Sex/Gender, Customized
Core Participants not enrolled in the Extension
|
2 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
23 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0 to 48 weeksPopulation: Extension Per-protocol population including all participants of the per protocol population who also were part of the extension safety population.
Mean absolute change in serum ferritin from baseline to the end of the extension study.
Outcome measures
| Measure |
Deferasirox (ICL670) 5 mg/kg/Day
n=9 Participants
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 10 mg/kg/Day
n=6 Participants
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 15 mg/kg/Day
n=11 Participants
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
|---|---|---|---|
|
Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population)
|
-389.1 µg/L
Standard Deviation 185.35
|
-610.5 µg/L
Standard Deviation 341.84
|
-571.6 µg/L
Standard Deviation 552.81
|
SECONDARY outcome
Timeframe: 4, 8, 12, 16, 20, and 24 weeksPopulation: Per-protocol population included all participants of the safety population; who received at least one dose of study drug within the core study and had at least one safety assessment, and who did not have any major protocol deviation. n in each of the Categories is the number of participants in each arm/group who had data for that time point.
A blood sample was collected just prior to administration of the next dose of Deferasirox (pre-dose trough level) or approximately 24 hours after the previous dose at weeks 4, 8, 12, 16, 20 and 24. The mean trough concentration at each time point was calculated.
Outcome measures
| Measure |
Deferasirox (ICL670) 5 mg/kg/Day
n=11 Participants
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 10 mg/kg/Day
n=15 Participants
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 15 mg/kg/Day
n=22 Participants
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
|---|---|---|---|
|
Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population)
Week 12 (n=10,12,13)
|
10.58 µmol/L
Standard Deviation 11.752
|
28.71 µmol/L
Standard Deviation 23.849
|
23.39 µmol/L
Standard Deviation 11.403
|
|
Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population)
Week 4 (n=10,14,17)
|
9.63 µmol/L
Standard Deviation 8.783
|
19.62 µmol/L
Standard Deviation 9.502
|
30.48 µmol/L
Standard Deviation 20.201
|
|
Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population)
Week 8 (n=10,12,17)
|
8.86 µmol/L
Standard Deviation 5.828
|
23.88 µmol/L
Standard Deviation 22.787
|
27.06 µmol/L
Standard Deviation 21.686
|
|
Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population)
Week 16 (n=10,11,11)
|
12.38 µmol/L
Standard Deviation 11.634
|
21.62 µmol/L
Standard Deviation 16.539
|
21.80 µmol/L
Standard Deviation 18.713
|
|
Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population)
Week 20 (n=9,10,8)
|
11.72 µmol/L
Standard Deviation 10.316
|
26.47 µmol/L
Standard Deviation 17.934
|
27.58 µmol/L
Standard Deviation 25.324
|
|
Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population)
Week 24 (n=10,9,6)
|
14.62 µmol/L
Standard Deviation 12.216
|
21.32 µmol/L
Standard Deviation 21.840
|
26.83 µmol/L
Standard Deviation 11.178
|
Adverse Events
Deferasirox (ICL670) 5 mg/kg/day_Core Study
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Deferasirox (ICL670) 10 mg/kg/day_Core Study
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Deferasirox (ICL670) 15 mg/kg/day_Core Study
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Deferasirox (ICL670) 5 mg/kg/day_Extension Study
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Deferasirox (ICL670) 10 mg/kg/day_Extension Study
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Deferasirox (ICL670) 15 mg/kg/day_Extension Study
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Deferasirox (ICL670) 5 mg/kg/day_Core Study
n=11 participants at risk
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 10 mg/kg/day_Core Study
n=15 participants at risk
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 15 mg/kg/day_Core Study
n=23 participants at risk
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 5 mg/kg/day_Extension Study
n=9 participants at risk
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 10 mg/kg/day_Extension Study
n=6 participants at risk
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 15 mg/kg/day_Extension Study
n=11 participants at risk
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
Other adverse events
| Measure |
Deferasirox (ICL670) 5 mg/kg/day_Core Study
n=11 participants at risk
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 10 mg/kg/day_Core Study
n=15 participants at risk
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 15 mg/kg/day_Core Study
n=23 participants at risk
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 5 mg/kg/day_Extension Study
n=9 participants at risk
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 10 mg/kg/day_Extension Study
n=6 participants at risk
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
Deferasirox (ICL670) 15 mg/kg/day_Extension Study
n=11 participants at risk
Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
13.3%
2/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
4.3%
1/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
33.3%
2/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
18.2%
2/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
26.7%
4/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
8.7%
2/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
33.3%
3/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
33.3%
2/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Cardiac disorders
Arrhythmia
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
8.7%
2/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Ear and labyrinth disorders
Mixed deafness
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Ear and labyrinth disorders
Neurosensory hypoacusis
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Ear and labyrinth disorders
Vertigo
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
22.2%
2/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Eye disorders
Blindness day
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Eye disorders
Cataract
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
4.3%
1/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Eye disorders
Corneal opacity
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Eye disorders
Eye pain
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Eye disorders
Maculopathy
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Eye disorders
Presbyopia
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Eye disorders
Vision blurred
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Eye disorders
Visual impairment
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
4.3%
1/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
8.7%
2/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
20.0%
3/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
17.4%
4/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
18.2%
2/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
2/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
40.0%
6/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
43.5%
10/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
22.2%
2/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
36.4%
4/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
13.3%
2/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
4.3%
1/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
33.3%
2/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Flatulence
|
18.2%
2/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
8.7%
2/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
18.2%
2/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
4.3%
1/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
13.3%
2/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
26.1%
6/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
36.4%
4/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
13.0%
3/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
18.2%
2/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
General disorders
Asthenia
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
General disorders
Chest discomfort
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
General disorders
Fatigue
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
8.7%
2/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
22.2%
2/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
General disorders
Influenza like illness
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
8.7%
2/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
18.2%
2/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
General disorders
Oedema peripheral
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
General disorders
Pyrexia
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
13.3%
2/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Immune system disorders
Drug hypersensitivity
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
4.3%
1/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
8.7%
2/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
4.3%
1/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Infections and infestations
Influenza
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
13.0%
3/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Infections and infestations
Pharyngitis
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Infections and infestations
Sinusitis
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
4.3%
1/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
27.3%
3/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Injury, poisoning and procedural complications
Injury
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
20.0%
3/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
13.0%
3/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
18.2%
2/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
4.3%
1/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Investigations
Blood creatine increased
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
20.0%
3/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
17.4%
4/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
33.3%
2/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
27.3%
3/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Investigations
Creatinine renal clearance increased
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Investigations
Transaminases increased
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
8.7%
2/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Investigations
White blood cell count increased
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
4.3%
1/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
18.2%
2/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Nervous system disorders
Headache
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
13.3%
2/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
30.4%
7/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
45.5%
5/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
13.3%
2/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
4.3%
1/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
27.3%
3/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
17.4%
4/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
18.2%
2/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
6.7%
1/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
16.7%
1/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Vascular disorders
Hypertension
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
4.3%
1/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Vascular disorders
Orthostatic hypotension
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
11.1%
1/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/15
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/23
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/9
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
0.00%
0/6
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
9.1%
1/11
Safety Population includes all participants who received at least one dose of study drug and had at least one safety assessment.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER