Trial Outcomes & Findings for Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome (NCT NCT03951077)
NCT ID: NCT03951077
Last Updated: 2022-06-08
Results Overview
A participant was considered a menstrual cycle responder if she has at least 2 normal menstrual cycles during the final 4 months of the treatment period. In addition, a participant was considered a complete menstrual cycle responder if she has normal menstrual cycles beginning at or before Month 3 that are maintained through Month 6 during the treatment period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
Week 0 (Baseline) to Week 24 (Month 6)
Results posted on
2022-06-08
Participant Flow
Participants were randomized 2:2:2:2:2:3 to the following treatments: 25 mg twice daily (BID), 50 mg once daily (QD), 75 mg BID, 150 mg QD, 300 mg QD, or placebo.
Participant milestones
| Measure |
Placebo
Placebo taken orally BID
|
Elagolix 25 mg BID
Elagolix 25 mg taken orally BID plus placebo
|
Elagolix 50 mg QD
Elagolix 50 mg taken orally QD plus placebo
|
Elagolix 75 mg BID
Elagolix 75 mg taken orally BID plus placebo
|
Elagolix 150 mg QD
Elagolix 150 mg taken orally QD plus placebo
|
Elagolix 300 mg QD
Elagolix 300 mg taken orally QD plus placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
18
|
18
|
18
|
19
|
18
|
|
Overall Study
Randomized and Treated
|
26
|
18
|
17
|
17
|
18
|
18
|
|
Overall Study
COMPLETED
|
9
|
4
|
5
|
6
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
18
|
14
|
13
|
12
|
16
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Placebo taken orally BID
|
Elagolix 25 mg BID
Elagolix 25 mg taken orally BID plus placebo
|
Elagolix 50 mg QD
Elagolix 50 mg taken orally QD plus placebo
|
Elagolix 75 mg BID
Elagolix 75 mg taken orally BID plus placebo
|
Elagolix 150 mg QD
Elagolix 150 mg taken orally QD plus placebo
|
Elagolix 300 mg QD
Elagolix 300 mg taken orally QD plus placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
0
|
3
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
3
|
2
|
3
|
|
Overall Study
Non-Compliance With Study Procedures
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Other, Not Specified
|
12
|
10
|
10
|
5
|
9
|
6
|
|
Overall Study
Did Not Receive Any Study Drug
|
1
|
0
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Baseline characteristics by cohort
| Measure |
Placebo
n=26 Participants
Placebo taken orally BID
|
Elagolix 25 mg BID
n=18 Participants
Elagolix 25 mg taken orally BID plus placebo
|
Elagolix 50 mg QD
n=17 Participants
Elagolix 50 mg taken orally QD plus placebo
|
Elagolix 75 mg BID
n=17 Participants
Elagolix 75 mg taken orally BID plus placebo
|
Elagolix 150 mg QD
n=18 Participants
Elagolix 150 mg taken orally QD plus placebo
|
Elagolix 300 mg QD
n=18 Participants
Elagolix 300 mg taken orally QD plus placebo
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 4.60 • n=5 Participants
|
25.3 years
STANDARD_DEVIATION 5.19 • n=7 Participants
|
27.6 years
STANDARD_DEVIATION 4.85 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 3.27 • n=4 Participants
|
25.1 years
STANDARD_DEVIATION 4.19 • n=21 Participants
|
26.1 years
STANDARD_DEVIATION 4.35 • n=8 Participants
|
26.5 years
STANDARD_DEVIATION 4.50 • n=8 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
114 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
87 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
85 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Body Mass Index (BMI)
< 30 kg/m^2
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Body Mass Index (BMI)
≥ 30 kg/m^2
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
81 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 0 (Baseline) to Week 24 (Month 6)Population: Full Analysis Set: all randomly assigned participants who have received at least one dose of study drug in this study. Based on observed cases only.
A participant was considered a menstrual cycle responder if she has at least 2 normal menstrual cycles during the final 4 months of the treatment period. In addition, a participant was considered a complete menstrual cycle responder if she has normal menstrual cycles beginning at or before Month 3 that are maintained through Month 6 during the treatment period.
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo taken orally BID
|
Elagolix 25 mg BID
n=18 Participants
Elagolix 25 mg taken orally BID plus placebo
|
Elagolix 50 mg QD
n=17 Participants
Elagolix 50 mg taken orally QD plus placebo
|
Elagolix 75 mg BID
n=17 Participants
Elagolix 75 mg taken orally BID plus placebo
|
Elagolix 150 mg QD
n=18 Participants
Elagolix 150 mg taken orally QD plus placebo
|
Elagolix 300 mg QD
n=18 Participants
Elagolix 300 mg taken orally QD plus placebo
|
|---|---|---|---|---|---|---|
|
Percentage of Menstrual Cycle Responders
|
7.7 percentage of participants
Interval 0.0 to 16.29
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
5.6 percentage of participants
Interval 0.0 to 14.44
|
SECONDARY outcome
Timeframe: Week 0 (Baseline), Week 1: before the morning dose (0 hour) and at 0.5 (± 5 minutes), 1 (± 5 minutes), 1.5 (± 5 minutes), 2 (± 15 minutes), 2.5 (± 15 minutes), 3 (± 15 minutes), 3.5 (± 15 minutes), and 4 (± 15 minutes) hours after dosing.Population: Full Analysis Set: all randomly assigned participants who have received at least one dose of study drug in this study. Participants with an assessment.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo taken orally BID
|
Elagolix 25 mg BID
n=15 Participants
Elagolix 25 mg taken orally BID plus placebo
|
Elagolix 50 mg QD
n=15 Participants
Elagolix 50 mg taken orally QD plus placebo
|
Elagolix 75 mg BID
n=16 Participants
Elagolix 75 mg taken orally BID plus placebo
|
Elagolix 150 mg QD
n=13 Participants
Elagolix 150 mg taken orally QD plus placebo
|
Elagolix 300 mg QD
n=15 Participants
Elagolix 300 mg taken orally QD plus placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1
|
-1.82 (IU/L)*hr
Standard Error 2.292
|
-7.75 (IU/L)*hr
Standard Error 2.867
|
-10.65 (IU/L)*hr
Standard Error 2.861
|
-17.92 (IU/L)*hr
Standard Error 2.692
|
-7.97 (IU/L)*hr
Standard Error 3.112
|
-13.54 (IU/L)*hr
Standard Error 2.763
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Elagolix 25 mg BID
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Elagolix 50 mg QD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Elagolix 75 mg BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Elagolix 150 mg QD
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Elagolix 300 mg QD
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=26 participants at risk
Placebo taken orally BID
|
Elagolix 25 mg BID
n=18 participants at risk
Elagolix 25 mg taken orally BID plus placebo
|
Elagolix 50 mg QD
n=17 participants at risk
Elagolix 50 mg taken orally QD plus placebo
|
Elagolix 75 mg BID
n=17 participants at risk
Elagolix 75 mg taken orally BID plus placebo
|
Elagolix 150 mg QD
n=18 participants at risk
Elagolix 150 mg taken orally QD plus placebo
|
Elagolix 300 mg QD
n=18 participants at risk
Elagolix 300 mg taken orally QD plus placebo
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
Other adverse events
| Measure |
Placebo
n=26 participants at risk
Placebo taken orally BID
|
Elagolix 25 mg BID
n=18 participants at risk
Elagolix 25 mg taken orally BID plus placebo
|
Elagolix 50 mg QD
n=17 participants at risk
Elagolix 50 mg taken orally QD plus placebo
|
Elagolix 75 mg BID
n=17 participants at risk
Elagolix 75 mg taken orally BID plus placebo
|
Elagolix 150 mg QD
n=18 participants at risk
Elagolix 150 mg taken orally QD plus placebo
|
Elagolix 300 mg QD
n=18 participants at risk
Elagolix 300 mg taken orally QD plus placebo
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Endocrine disorders
HYPERANDROGENISM
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
3.8%
1/26 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Gastrointestinal disorders
NAUSEA
|
11.5%
3/26 • Number of events 3 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Gastrointestinal disorders
SALIVARY GLAND CYST
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
General disorders
FATIGUE
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
General disorders
PYREXIA
|
3.8%
1/26 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Infections and infestations
COVID-19
|
3.8%
1/26 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Infections and infestations
CHRONIC TONSILLITIS
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.8%
1/26 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Infections and infestations
ORAL BACTERIAL INFECTION
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Infections and infestations
PILONIDAL CYST
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Infections and infestations
SCHISTOSOMIASIS CUTANEOUS
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.8%
1/26 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Infections and infestations
VULVOVAGINAL CANDIDIASIS
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Injury, poisoning and procedural complications
NAIL AVULSION
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Investigations
BLOOD INSULIN INCREASED
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
3.8%
1/26 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Investigations
BONE DENSITY DECREASED
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Investigations
LIPIDS INCREASED
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Investigations
LIVER FUNCTION TEST INCREASED
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.7%
2/26 • Number of events 2 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Nervous system disorders
HEADACHE
|
3.8%
1/26 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Psychiatric disorders
ATTENTION DEFICIT HYPERACTIVITY DISORDER
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Psychiatric disorders
DEPRESSION
|
3.8%
1/26 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Psychiatric disorders
MOOD SWINGS
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Psychiatric disorders
STRESS
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Reproductive system and breast disorders
AMENORRHOEA
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Reproductive system and breast disorders
DYSFUNCTIONAL UTERINE BLEEDING
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Reproductive system and breast disorders
PELVIC DISCOMFORT
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Reproductive system and breast disorders
PREMENSTRUAL SYNDROME
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Respiratory, thoracic and mediastinal disorders
ADENOIDAL HYPERTROPHY
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Respiratory, thoracic and mediastinal disorders
TONSILLAR HYPERTROPHY
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 2 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Skin and subcutaneous tissue disorders
SKIN IRRITATION
|
0.00%
0/26 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/18 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
|
Vascular disorders
HOT FLUSH
|
7.7%
2/26 • Number of events 2 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
0.00%
0/17 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER