Trial Outcomes & Findings for Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine (NCT NCT01820559)
NCT ID: NCT01820559
Last Updated: 2013-05-24
Results Overview
The primary efficacy variable was the absolute change from baseline in the frequency of migraine attacks standardised to 4 weeks in the Maintenance Period, as recorded in the subject diary. If there were less than 24 h between the end of 1 migraine event and the start of the next event, these 2 events were considered to belong to 1 migraine attack. There had to be a minimum of 24 h of freedom from headache, pain, and symptoms of migraine between attacks recorded in the subject diary to be considered as more than 1 attack of migraine for statistical analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
452 participants
Primary outcome timeframe
4 weeks
Results posted on
2013-05-24
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo tablets
Placebo : Tablets
|
ESL 800 mg
eslicarbazepine acetate 800 mg
ESL 800 mg :
|
ESL 1200 mg
eslicarbazepine acetate 1200 mg
ESL 1200 mg :
|
|---|---|---|---|
|
Overall Study
STARTED
|
136
|
135
|
139
|
|
Overall Study
Randomized and Treated
|
136
|
135
|
139
|
|
Overall Study
Completed Tutration Period
|
130
|
134
|
131
|
|
Overall Study
Entered Maintenance Period
|
129
|
133
|
129
|
|
Overall Study
Completed Maintenance Period
|
122
|
123
|
110
|
|
Overall Study
COMPLETED
|
122
|
122
|
110
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
29
|
Reasons for withdrawal
| Measure |
Placebo
Placebo tablets
Placebo : Tablets
|
ESL 800 mg
eslicarbazepine acetate 800 mg
ESL 800 mg :
|
ESL 1200 mg
eslicarbazepine acetate 1200 mg
ESL 1200 mg :
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
6
|
13
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
5
|
|
Overall Study
Protocol Violation
|
2
|
1
|
3
|
|
Overall Study
Subject's non-compliance
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
2
|
|
Overall Study
At sponsor request
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
2
|
3
|
Baseline Characteristics
Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine
Baseline characteristics by cohort
| Measure |
Placebo
n=136 Participants
Placebo tablets
Placebo : Tablets
|
ESL 800 mg
n=135 Participants
eslicarbazepine acetate 800 mg
ESL 800 mg :
|
ESL 1200 mg
n=139 Participants
eslicarbazepine acetate 1200 mg
ESL 1200 mg :
|
Total
n=410 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<=65 years
|
135 participants
n=5 Participants
|
135 participants
n=7 Participants
|
136 participants
n=5 Participants
|
406 participants
n=4 Participants
|
|
Age, Customized
>65 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
346 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeksThe primary efficacy variable was the absolute change from baseline in the frequency of migraine attacks standardised to 4 weeks in the Maintenance Period, as recorded in the subject diary. If there were less than 24 h between the end of 1 migraine event and the start of the next event, these 2 events were considered to belong to 1 migraine attack. There had to be a minimum of 24 h of freedom from headache, pain, and symptoms of migraine between attacks recorded in the subject diary to be considered as more than 1 attack of migraine for statistical analysis.
Outcome measures
| Measure |
Placebo
n=133 Participants
Placebo tablets
Placebo : Tablets
|
ESL 800 mg
n=134 Participants
eslicarbazepine acetate 800 mg
ESL 800 mg :
|
ESL 1200 mg
n=136 Participants
eslicarbazepine acetate 1200 mg
ESL 1200 mg :
|
|---|---|---|---|
|
Absolute Change From Baseline in the Frequency of Migraine Attacks
|
-0.8 number of migraine attacks/participant
Standard Error 0.1429
|
-1.0 number of migraine attacks/participant
Standard Error 0.1428
|
-1.0 number of migraine attacks/participant
Standard Error 0.1416
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
ESL 800 mg
Serious events: 1 serious events
Other events: 67 other events
Deaths: 0 deaths
ESL 1200 mg
Serious events: 4 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=136 participants at risk
Placebo tablets
Placebo : Tablets
|
ESL 800 mg
n=135 participants at risk
eslicarbazepine acetate 800 mg
ESL 800 mg :
|
ESL 1200 mg
n=139 participants at risk
eslicarbazepine acetate 1200 mg
ESL 1200 mg :
|
|---|---|---|---|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
0.00%
0/136 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.00%
0/135 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.72%
1/139 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Infections and infestations
VIRAL INFECTION
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.00%
0/135 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.72%
1/139 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Nervous system disorders
STATUS MIGRAINOSUS
|
0.00%
0/136 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.72%
1/139 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Psychiatric disorders
ADJUSTMENT DISORDER
|
0.00%
0/136 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.00%
0/135 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.72%
1/139 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
Other adverse events
| Measure |
Placebo
n=136 participants at risk
Placebo tablets
Placebo : Tablets
|
ESL 800 mg
n=135 participants at risk
eslicarbazepine acetate 800 mg
ESL 800 mg :
|
ESL 1200 mg
n=139 participants at risk
eslicarbazepine acetate 1200 mg
ESL 1200 mg :
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
4/136 • Number of events 4 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.00%
0/135 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.00%
0/139 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
3/136 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.00%
0/139 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/136 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/135 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.00%
0/139 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Nervous system disorders
Tension headache
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/139 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/136 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/139 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Nervous system disorders
Status migrainosus
|
0.00%
0/136 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
1.5%
2/135 • Number of events 2 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/139 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
General disorders
Face oedema
|
0.00%
0/136 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.00%
0/135 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/139 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Endocrine disorders
Hypothyroidism
|
1.5%
2/136 • Number of events 2 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/135 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
1.4%
2/139 • Number of events 2 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.2%
3/136 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/135 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
1.4%
2/139 • Number of events 2 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Vascular disorders
Hypertension
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/135 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.72%
1/139 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Nervous system disorders
Insomnia
|
2.2%
3/136 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.74%
1/135 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.72%
1/139 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Infections and infestations
Upper respiratory tract infection
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/135 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.72%
1/139 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Investigations
Blood creatine phosphokinase increased
|
1.5%
2/136 • Number of events 2 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/135 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
0.72%
1/139 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Nervous system disorders
Dizziness
|
1.5%
2/136 • Number of events 2 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
4.4%
6/135 • Number of events 6 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
10.1%
14/139 • Number of events 14 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Nervous system disorders
Somnolence
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
6.7%
9/135 • Number of events 9 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
9.4%
13/139 • Number of events 13 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Ear and labyrinth disorders
Vertigo
|
2.9%
4/136 • Number of events 4 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
3.0%
4/135 • Number of events 4 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
7.9%
11/139 • Number of events 11 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Gastrointestinal disorders
Nausea
|
2.9%
4/136 • Number of events 4 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
4.4%
6/135 • Number of events 6 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
7.2%
10/139 • Number of events 10 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Nervous system disorders
Migraine
|
2.2%
3/136 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
1.5%
2/135 • Number of events 2 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
4.3%
6/139 • Number of events 6 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
6/136 • Number of events 6 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
3.7%
5/135 • Number of events 5 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.9%
4/139 • Number of events 4 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
3/136 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
1.5%
2/135 • Number of events 2 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/139 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
General disorders
Fatigue
|
0.74%
1/136 • Number of events 1 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
3.0%
4/135 • Number of events 4 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/139 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
General disorders
Influenza
|
1.5%
2/136 • Number of events 2 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/135 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/139 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
|
General disorders
Asthenia
|
0.00%
0/136 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
1.5%
2/135 • Number of events 2 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
2.2%
3/139 • Number of events 3 • Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
|
Additional Information
Head of Clinical Research Section
BIAL - Portela & Ca, SA
Phone: 351 22 986 6100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER