Trial Outcomes & Findings for A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures (NCT NCT00698581)
NCT ID: NCT00698581
Last Updated: 2018-07-11
Results Overview
The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
88 participants
Primary outcome timeframe
From Week 1 up to Week 17
Results posted on
2018-07-11
Participant Flow
This study started to enroll patients in August 2008 and concluded in February 2010.
The Participant Flow refers to the Randomized Set (RS). Subjects withdrawn due to meeting an exit criterion are included in the count of early discontinuations with a reason of "Adverse Event" or "Lack of efficacy" as reported by the Investigator.
Participant milestones
| Measure |
Brivaracetam 50 mg/Day
Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg \> 20 mg) for subjects not participating in the follow-up study)
|
Brivaracetam 100 mg/Day
Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
20
|
|
Overall Study
COMPLETED
|
23
|
8
|
|
Overall Study
NOT COMPLETED
|
45
|
12
|
Reasons for withdrawal
| Measure |
Brivaracetam 50 mg/Day
Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg \> 20 mg) for subjects not participating in the follow-up study)
|
Brivaracetam 100 mg/Day
Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
23
|
11
|
|
Overall Study
Withdrawal by Subject
|
6
|
0
|
|
Overall Study
Other reason
|
9
|
1
|
|
Overall Study
SAE, non-fatal
|
1
|
0
|
|
Overall Study
AE, non-serious non-fatal
|
4
|
0
|
|
Overall Study
SAE, non-fatal+AE, non-serious non-fatal
|
1
|
0
|
|
Overall Study
AE of unknown type
|
1
|
0
|
Baseline Characteristics
A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures
Baseline characteristics by cohort
| Measure |
Brivaracetam 50 mg/Day
n=68 Participants
Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg \> 20 mg) for subjects not participating in the follow-up study)
|
Brivaracetam 100 mg/Day
n=20 Participants
Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)
|
Total Title
n=88 Participants
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
43.6 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
39.0 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Age, Customized
< 65 years
|
66 participants
n=5 Participants
|
19 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Week 1 up to Week 17Population: The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.
The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.
Outcome measures
| Measure |
Efficacy Analysis Set (BRV 50 mg/Day Treated Subjects)
n=67 Participants
The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.
|
Brivaracetam 100 mg/Day
Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)
|
|---|---|---|
|
The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase
|
0.487 proportion of subjects
Interval 0.347 to 0.626
|
—
|
SECONDARY outcome
Timeframe: Baseline through Re-conversion (approximately 31 weeks)Population: The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.
Outcome measures
| Measure |
Efficacy Analysis Set (BRV 50 mg/Day Treated Subjects)
n=68 Participants
The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.
|
Brivaracetam 100 mg/Day
n=20 Participants
Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)
|
|---|---|---|
|
The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study
|
53 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline through Re-conversion (approximately 31 weeks)Population: The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.
Outcome measures
| Measure |
Efficacy Analysis Set (BRV 50 mg/Day Treated Subjects)
n=68 Participants
The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.
|
Brivaracetam 100 mg/Day
n=20 Participants
Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)
|
|---|---|---|
|
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline through Re-conversion (approximately 31 weeks)Population: The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.
Outcome measures
| Measure |
Efficacy Analysis Set (BRV 50 mg/Day Treated Subjects)
n=68 Participants
The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.
|
Brivaracetam 100 mg/Day
n=20 Participants
Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)
|
|---|---|---|
|
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
|
5 Participants
|
0 Participants
|
Adverse Events
Brivaracetam 50 mg/Day
Serious events: 5 serious events
Other events: 33 other events
Deaths: 0 deaths
Brivaracetam 100 mg/Day
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brivaracetam 50 mg/Day
n=68 participants at risk
Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg \> 20 mg) for subjects not participating in the follow-up study)
|
Brivaracetam 100 mg/Day
n=20 participants at risk
Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
1.5%
1/68 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Nervous system disorders
Grand mal convulsion
|
2.9%
2/68 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Nervous system disorders
Dizziness
|
1.5%
1/68 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Nervous system disorders
Loss of consciousness
|
1.5%
1/68 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Nervous system disorders
Paraesthesia
|
1.5%
1/68 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Nervous system disorders
Status epilepticus
|
1.5%
1/68 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Psychiatric disorders
Anxiety
|
1.5%
1/68 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
Other adverse events
| Measure |
Brivaracetam 50 mg/Day
n=68 participants at risk
Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg \> 20 mg) for subjects not participating in the follow-up study)
|
Brivaracetam 100 mg/Day
n=20 participants at risk
Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)
|
|---|---|---|
|
General disorders
Fatigue
|
7.4%
5/68 • Number of events 5 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Gastrointestinal disorders
Nausea
|
4.4%
3/68 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
10.0%
2/20 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
4/68 • Number of events 5 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/68 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.8%
6/68 • Number of events 7 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
2/68 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Nervous system disorders
Headache
|
13.2%
9/68 • Number of events 10 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Nervous system disorders
Convulsion
|
4.4%
3/68 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
20.0%
4/20 • Number of events 5 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Nervous system disorders
Somnolence
|
5.9%
4/68 • Number of events 4 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/68 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Psychiatric disorders
Anxiety
|
8.8%
6/68 • Number of events 6 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Psychiatric disorders
Depression
|
10.3%
7/68 • Number of events 7 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Psychiatric disorders
Insomnia
|
7.4%
5/68 • Number of events 6 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
|
Vascular disorders
Hot flush
|
0.00%
0/68 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
|
Additional Information
UCB Cares
UCB
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60