Trial Outcomes & Findings for A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis (NCT NCT01116440)
NCT ID: NCT01116440
Last Updated: 2020-11-23
Results Overview
Mean change from baseline to Month 3 (Week 12) in Number Rating Scale pelvic pain score. The Numeric Rating Scale is a scale between 0 and 10 where 0 is no pain and 10 is the worse pain you can imagine.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-11-23
Participant Flow
Participant milestones
| Measure |
BGS649 Co-administered With Levora 28™
BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg will be administered at randomization, week 4, and week 8 at the study site.
|
Placebo Co-administered With Levora 28™
Placebo: Placebo matching BGS649 will be provided by Novartis as capsules for oral administration. Three capsules of placebo will be administered at randomization, week 4, and week 8 at the study site.
|
|---|---|---|
|
Treatment
STARTED
|
11
|
16
|
|
Treatment
COMPLETED
|
8
|
9
|
|
Treatment
NOT COMPLETED
|
3
|
7
|
|
Withdrawal
STARTED
|
8
|
9
|
|
Withdrawal
COMPLETED
|
8
|
7
|
|
Withdrawal
NOT COMPLETED
|
0
|
2
|
|
Follow-up
STARTED
|
8
|
7
|
|
Follow-up
COMPLETED
|
8
|
5
|
|
Follow-up
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
BGS649 Co-administered With Levora 28™
BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg will be administered at randomization, week 4, and week 8 at the study site.
|
Placebo Co-administered With Levora 28™
Placebo: Placebo matching BGS649 will be provided by Novartis as capsules for oral administration. Three capsules of placebo will be administered at randomization, week 4, and week 8 at the study site.
|
|---|---|---|
|
Treatment
Withdrawal by Subject
|
2
|
2
|
|
Treatment
Lost to Follow-up
|
1
|
1
|
|
Treatment
Protocol Violation
|
0
|
2
|
|
Treatment
Lack of Efficacy
|
0
|
1
|
|
Treatment
Adverse Event
|
0
|
1
|
|
Withdrawal
Withdrawal by Subject
|
0
|
1
|
|
Withdrawal
Lost to Follow-up
|
0
|
1
|
|
Follow-up
Lost to Follow-up
|
0
|
1
|
|
Follow-up
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis
Baseline characteristics by cohort
| Measure |
BGS649 Co-administered With Levora 28™
n=11 Participants
BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg administered at randomization, week 4, and week 8 at the study site.
|
Placebo Co-administered With Levora 28™
n=16 Participants
Placebo: Placebo matching BGS649 provided by Novartis as capsules for oral administration. Three capsules of placebo administered at randomization, week 4, and week 8 at the study site.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 5.75 • n=5 Participants
|
29.4 years
STANDARD_DEVIATION 5.67 • n=7 Participants
|
29.4 years
STANDARD_DEVIATION 5.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Body Mass Index
|
27.9 kg/m^2
STANDARD_DEVIATION 4.98 • n=5 Participants
|
25.6 kg/m^2
STANDARD_DEVIATION 4.11 • n=7 Participants
|
26.6 kg/m^2
STANDARD_DEVIATION 4.54 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Full analysis set. All patients randomised excluding those who were randomised inadvertently and did not receive study drug
Mean change from baseline to Month 3 (Week 12) in Number Rating Scale pelvic pain score. The Numeric Rating Scale is a scale between 0 and 10 where 0 is no pain and 10 is the worse pain you can imagine.
Outcome measures
| Measure |
BGS649 Co-administered With Levora 28™
n=11 Participants
BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg administered at randomization, week 4, and week 8 at the study site.
|
Placebo Co-administered With Levora 28™
n=16 Participants
Placebo: Placebo matching BGS649 provided by Novartis as capsules for oral administration. Three capsules of placebo administered at randomization, week 4, and week 8 at the study site.
|
|---|---|---|
|
Mean Change in Baseline to Week 12 in Numeric Rating Scale Pelvic Pain Score
|
-0.7637 units on a scale
Standard Deviation 2.12386
|
-2.1706 units on a scale
Standard Deviation 2.27246
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Full Analysis Set. All randomized patients excluding patients randomized inadvertently who did not receive drug (ITT)
Mean change from baseline in Numeric Rating Scale pelvic pain scores to 4 weeks. The Numeric Rating Scale is a scale between 0 and 10 where 0 is no pain and 10 is the worse pain you can imagine.
Outcome measures
| Measure |
BGS649 Co-administered With Levora 28™
n=11 Participants
BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg administered at randomization, week 4, and week 8 at the study site.
|
Placebo Co-administered With Levora 28™
n=16 Participants
Placebo: Placebo matching BGS649 provided by Novartis as capsules for oral administration. Three capsules of placebo administered at randomization, week 4, and week 8 at the study site.
|
|---|---|---|
|
Mean Change From Baseline to 4 Weeks in Numeric Rating Scale Pelvic Pain Scores
|
-0.6596 score on a scale
Standard Deviation 1.34546
|
-0.9282 score on a scale
Standard Deviation 1.05794
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set. All participants randomized except patients inadvertently randomized who didn't receive study drug (ITT principles)
The proportion (expressed as a percentage) of patients achieving a response in the Numeric Rating Scale pelvic pain score where a response is defined as greater than or equal to 2-point improvement from baseline or a greater than or equal to 30% improvement in the score. The Numeric Rating Scale is a scale between 0 and 10 where 0 is no pain and 10 is the worse pain you can imagine.
Outcome measures
| Measure |
BGS649 Co-administered With Levora 28™
n=11 Participants
BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg administered at randomization, week 4, and week 8 at the study site.
|
Placebo Co-administered With Levora 28™
n=16 Participants
Placebo: Placebo matching BGS649 provided by Novartis as capsules for oral administration. Three capsules of placebo administered at randomization, week 4, and week 8 at the study site.
|
|---|---|---|
|
Percentage of Patients Achieving a Response in Numeric Rating Scale Pelvic Pain Score
|
9.1 percentage of participants
|
37.5 percentage of participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Full Analysis Set. All randomized patients excluding patients randomized inadvertently who did not receive drug (ITT)
Mean change from baseline in Numeric Rating Scale pelvic pain scores to 8 weeks. Where the Numeric Rate Scale Pelvic Pain Score is a scale between 0 and 10, where 0 is no pain and is the worse pain you can imagine.
Outcome measures
| Measure |
BGS649 Co-administered With Levora 28™
n=11 Participants
BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg administered at randomization, week 4, and week 8 at the study site.
|
Placebo Co-administered With Levora 28™
n=16 Participants
Placebo: Placebo matching BGS649 provided by Novartis as capsules for oral administration. Three capsules of placebo administered at randomization, week 4, and week 8 at the study site.
|
|---|---|---|
|
Mean Change From Baseline in Numeric Rating Scale Pelvic Pain Scores
|
-1.2840 score on a scale
Standard Deviation 2.18569
|
-2.0601 score on a scale
Standard Deviation 2.11810
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set. All participants randomized except patients inadvertently randomized who didn't receive study drug (ITT principles)
The proportion of patients (expressed as a percentage) achieving a response to their pelvic pain score measure on the Biberoglu and Behrman pelvic pain score where a response is defined as a greater than or equal to 1-point improvement from baseline. B \& B scales allow for grading pain with a score between 0 and 4 with higher number being more severe pain.
Outcome measures
| Measure |
BGS649 Co-administered With Levora 28™
n=11 Participants
BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg administered at randomization, week 4, and week 8 at the study site.
|
Placebo Co-administered With Levora 28™
n=16 Participants
Placebo: Placebo matching BGS649 provided by Novartis as capsules for oral administration. Three capsules of placebo administered at randomization, week 4, and week 8 at the study site.
|
|---|---|---|
|
Percentage of Patients Achieving a Response in Their Pelvic Pain Score Measured on the Modified Biberoglu & Behrman Scale
|
0 percentage of participants
|
31.3 percentage of participants
|
Adverse Events
BGS649 Co-administered With Levora 28™
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Co-administered With Levora 28™
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BGS649 Co-administered With Levora 28™
n=12 participants at risk
BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg administered at randomization, week 4, and week 8 at the study site.
|
Placebo Co-administered With Levora 28™
n=15 participants at risk
Placebo: Placebo matching BGS649 provided by Novartis as capsules for oral administration. Three capsules of placebo administered at randomization, week 4, and week 8 at the study site.
|
|---|---|---|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
Other adverse events
| Measure |
BGS649 Co-administered With Levora 28™
n=12 participants at risk
BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg administered at randomization, week 4, and week 8 at the study site.
|
Placebo Co-administered With Levora 28™
n=15 participants at risk
Placebo: Placebo matching BGS649 provided by Novartis as capsules for oral administration. Three capsules of placebo administered at randomization, week 4, and week 8 at the study site.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Eye disorders
Vision blurred
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Gastrointestinal disorders
Gastritis
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 3
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
General disorders
Fatigue
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
General disorders
Irritability
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
General disorders
Oedema peripheral
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Infections and infestations
Gastroentritis viral
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
13.3%
2/15 • Number of events 2
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Investigations
Platelet count increased
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Investigations
Smear cervix abdominal
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Investigations
Weight increased
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Nervous system disorders
Amnesia
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
13.3%
2/15 • Number of events 2
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Nervous system disorders
Migraine
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Nervous system disorders
Psychiatric disorders
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Nervous system disorders
Confusional state
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Nervous system disorders
Insomnia
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Nervous system disorders
Mood swings
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
16.7%
2/12 • Number of events 2
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Reproductive system and breast disorders
Pelvic pain
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
13.3%
2/15 • Number of events 2
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Reproductive system and breast disorders
Premenstrual syndrome
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
8.3%
1/12 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
0.00%
0/15
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
|
Vascular disorders
Hot flush
|
0.00%
0/12
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
6.7%
1/15 • Number of events 1
After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All PIs must seek written permission from the sponsor prior to publication of any trial results.
- Publication restrictions are in place
Restriction type: OTHER