Trial Outcomes & Findings for A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA) (NCT NCT01904721)
NCT ID: NCT01904721
Last Updated: 2016-03-22
Results Overview
TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm\^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
244 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2016-03-22
Participant Flow
Participant milestones
| Measure |
Stage 1: Bimatoprost Solution 1 Twice Daily
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
|
Stage 1: Bimatoprost Solution 1 Once Daily
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
|
Stage 1: Bimatoprost Solution 2 Twice Daily
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
|
Stage 1: Bimatoprost Solution 2 Once Daily
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
|
Stage 2: Bimatoprost Solution 1 Twice Daily
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Solution 2 Twice Daily
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Vehicle Twice Daily
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
12
|
12
|
65
|
65
|
64
|
|
Overall Study
COMPLETED
|
13
|
13
|
11
|
11
|
57
|
56
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
8
|
9
|
7
|
Reasons for withdrawal
| Measure |
Stage 1: Bimatoprost Solution 1 Twice Daily
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
|
Stage 1: Bimatoprost Solution 1 Once Daily
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
|
Stage 1: Bimatoprost Solution 2 Twice Daily
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
|
Stage 1: Bimatoprost Solution 2 Once Daily
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
|
Stage 2: Bimatoprost Solution 1 Twice Daily
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Solution 2 Twice Daily
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Vehicle Twice Daily
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Other Reasons
|
0
|
0
|
1
|
1
|
2
|
2
|
2
|
|
Overall Study
Personal Reasons
|
0
|
0
|
0
|
0
|
2
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
Baseline Characteristics
A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)
Baseline characteristics by cohort
| Measure |
Stage 1: Bimatoprost Solution 1 Twice Daily
n=13 Participants
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
|
Stage 1: Bimatoprost Solution 1 Once Daily
n=13 Participants
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
|
Stage 1: Bimatoprost Solution 2 Twice Daily
n=12 Participants
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
|
Stage 1: Bimatoprost Solution 2 Once Daily
n=12 Participants
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
|
Stage 2: Bimatoprost Solution 2 Twice Daily
n=65 Participants
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Solution 1 Twice Daily
n=65 Participants
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Vehicle Twice Daily
n=64 Participants
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
≥18 to <35 years
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
66 Participants
n=24 Participants
|
|
Age, Customized
35 to 49 years
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
47 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
178 Participants
n=24 Participants
|
|
Sex/Gender, Customized
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
65 Participants
n=10 Participants
|
64 Participants
n=115 Participants
|
244 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm\^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).
Outcome measures
| Measure |
Stage 2: Bimatoprost Solution 2 Twice Daily
n=63 Participants
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Solution 1 Twice Daily
n=62 Participants
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Vehicle Twice Daily
n=60 Participants
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
|---|---|---|---|
|
Change From Baseline in Target Area Hair Count (TAHC)
Baseline
|
131.3 terminal hairs/cm2
Standard Deviation 55.53
|
140.4 terminal hairs/cm2
Standard Deviation 59.76
|
129.0 terminal hairs/cm2
Standard Deviation 57.42
|
|
Change From Baseline in Target Area Hair Count (TAHC)
Change from Baseline at Month 6
|
9.3 terminal hairs/cm2
Standard Deviation 23.09
|
12.7 terminal hairs/cm2
Standard Deviation 26.39
|
5.8 terminal hairs/cm2
Standard Deviation 20.95
|
PRIMARY outcome
Timeframe: Month 6Population: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Outcome measures
| Measure |
Stage 2: Bimatoprost Solution 2 Twice Daily
n=63 Participants
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Solution 1 Twice Daily
n=62 Participants
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Vehicle Twice Daily
n=60 Participants
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
|---|---|---|---|
|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Greatly increased
|
4.8 Percentage of Participants
|
6.5 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Moderately increased
|
25.4 Percentage of Participants
|
14.5 Percentage of Participants
|
6.7 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Slightly increased
|
33.3 Percentage of Participants
|
33.9 Percentage of Participants
|
20.0 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Remained the same
|
23.8 Percentage of Participants
|
30.6 Percentage of Participants
|
35.0 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Slightly decreased
|
12.7 Percentage of Participants
|
12.9 Percentage of Participants
|
30.0 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Moderately decreased
|
0.0 Percentage of Participants
|
1.6 Percentage of Participants
|
6.7 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Greatly decreased
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Month 6Population: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Outcome measures
| Measure |
Stage 2: Bimatoprost Solution 2 Twice Daily
n=63 Participants
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Solution 1 Twice Daily
n=62 Participants
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Vehicle Twice Daily
n=60 Participants
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
|---|---|---|---|
|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Greatly increased
|
4.8 Percentage of Participants
|
11.3 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Moderately increased
|
22.2 Percentage of Participants
|
17.7 Percentage of Participants
|
3.3 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Slightly increased
|
33.3 Percentage of Participants
|
25.8 Percentage of Participants
|
23.3 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Remained the same
|
36.5 Percentage of Participants
|
41.9 Percentage of Participants
|
60.0 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Slightly decreased
|
3.2 Percentage of Participants
|
3.2 Percentage of Participants
|
13.3 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Moderately decreased
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Greatly decreased
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Month 6Population: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Outcome measures
| Measure |
Stage 2: Bimatoprost Solution 2 Twice Daily
n=62 Participants
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Solution 1 Twice Daily
n=60 Participants
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Vehicle Twice Daily
n=58 Participants
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
|---|---|---|---|
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Greatly increased
|
1.6 Percentage of Participants
|
3.3 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Moderately increased
|
9.7 Percentage of Participants
|
15.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Slightly increased
|
40.3 Percentage of Participants
|
35.0 Percentage of Participants
|
15.5 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Remained the same
|
45.2 Percentage of Participants
|
43.3 Percentage of Participants
|
72.4 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Slightly decreased
|
3.2 Percentage of Participants
|
3.3 Percentage of Participants
|
10.3 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Moderately decreased
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.7 Percentage of Participants
|
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Greatly decreased
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm\^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).
Outcome measures
| Measure |
Stage 2: Bimatoprost Solution 2 Twice Daily
n=63 Participants
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Solution 1 Twice Daily
n=62 Participants
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Vehicle Twice Daily
n=60 Participants
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
|---|---|---|---|
|
Change From Baseline in Target Area Hair Width (TAHW)
Baseline
|
7.32 mm/cm2
Standard Deviation 3.472
|
7.82 mm/cm2
Standard Deviation 3.764
|
7.30 mm/cm2
Standard Deviation 3.550
|
|
Change From Baseline in Target Area Hair Width (TAHW)
Change from Baseline at Month 6
|
0.67 mm/cm2
Standard Deviation 1.185
|
0.92 mm/cm2
Standard Deviation 1.435
|
0.05 mm/cm2
Standard Deviation 1.018
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs).
Outcome measures
| Measure |
Stage 2: Bimatoprost Solution 2 Twice Daily
n=63 Participants
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Solution 1 Twice Daily
n=62 Participants
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Vehicle Twice Daily
n=60 Participants
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
|---|---|---|---|
|
Change From Baseline in Target Area Hair Darkness (TAHD)
Baseline
|
113.77 Intensity Units
Standard Deviation 19.458
|
115.76 Intensity Units
Standard Deviation 20.014
|
115.22 Intensity Units
Standard Deviation 19.879
|
|
Change From Baseline in Target Area Hair Darkness (TAHD)
Change from Baseline at Month 6
|
-1.63 Intensity Units
Standard Deviation 17.896
|
-6.31 Intensity Units
Standard Deviation 17.016
|
-1.62 Intensity Units
Standard Deviation 16.763
|
Adverse Events
Stage 1: Bimatoprost Solution 1 Twice Daily
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Stage 1: Bimatoprost Solution 1 Once Daily
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 1: Bimatoprost Solution 2 Twice Daily
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Stage 1: Bimatoprost Solution 2 Once Daily
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Stage 2: Bimatoprost Solution 2 Twice Daily
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Stage 2: Bimatoprost Solution 1 Twice Daily
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Stage 2: Bimatoprost Vehicle Twice Daily
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1: Bimatoprost Solution 1 Twice Daily
n=13 participants at risk
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
|
Stage 1: Bimatoprost Solution 1 Once Daily
n=13 participants at risk
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
|
Stage 1: Bimatoprost Solution 2 Twice Daily
n=12 participants at risk
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
|
Stage 1: Bimatoprost Solution 2 Once Daily
n=12 participants at risk
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
|
Stage 2: Bimatoprost Solution 2 Twice Daily
n=65 participants at risk
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Solution 1 Twice Daily
n=65 participants at risk
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Vehicle Twice Daily
n=64 participants at risk
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.5%
1/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.5%
1/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.5%
1/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.5%
1/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Scapula Fracture
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.5%
1/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.5%
1/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
Other adverse events
| Measure |
Stage 1: Bimatoprost Solution 1 Twice Daily
n=13 participants at risk
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
|
Stage 1: Bimatoprost Solution 1 Once Daily
n=13 participants at risk
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
|
Stage 1: Bimatoprost Solution 2 Twice Daily
n=12 participants at risk
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
|
Stage 1: Bimatoprost Solution 2 Once Daily
n=12 participants at risk
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
|
Stage 2: Bimatoprost Solution 2 Twice Daily
n=65 participants at risk
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Solution 1 Twice Daily
n=65 participants at risk
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
Stage 2: Bimatoprost Vehicle Twice Daily
n=64 participants at risk
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Application Site Erythema
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
4.6%
3/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
7.7%
5/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
3.1%
2/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
General disorders
Application Site Discoloration
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.5%
1/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
6.2%
4/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.6%
1/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Hair Growth Abnormal
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
8.3%
1/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
9.2%
6/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
3.1%
2/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
7.7%
5/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
9.2%
6/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
15.4%
2/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.5%
1/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.5%
1/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.6%
1/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
General disorders
Influenza Like Illness
|
15.4%
2/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
General disorders
Application Site Pruritus
|
7.7%
1/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
8.3%
1/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.5%
1/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
3.1%
2/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
16.7%
2/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
8.3%
1/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.5%
1/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
3.1%
2/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.6%
1/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Investigations
Electrocardiogram T Wave Amplitude Increased
|
7.7%
1/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
8.3%
1/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.7%
1/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
16.7%
2/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.6%
1/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Nervous system disorders
Headache
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
15.4%
2/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
4.6%
3/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.6%
1/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Growth of Eyelashes
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
15.4%
10/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Investigations
Blood Glucose Increased
|
7.7%
1/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.6%
1/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
7.7%
1/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.5%
1/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Investigations
Glucose Urine Present
|
7.7%
1/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
7.7%
1/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
7.7%
1/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Bundle Branch Block Left
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
7.7%
1/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.5%
1/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
7.7%
1/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Dry Eye
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
7.7%
1/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
3.1%
2/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
7.7%
1/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Corneal Irritation
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
8.3%
1/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
8.3%
1/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Ear Lobe Infection
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
8.3%
1/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
8.3%
1/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
1.5%
1/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
8.3%
1/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
8.3%
1/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/13
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
8.3%
1/12
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/65
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
0.00%
0/64
The safety population was defined as all patients who received study medication in the study. The safety population was used to assess adverse events and serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER