Trial Outcomes & Findings for Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia (NCT NCT00981227)
NCT ID: NCT00981227
Last Updated: 2014-10-29
Results Overview
The primary efficacy variable will be based upon an 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain, to be recorded in a patient's diary upon awakening each morning. This score should reflect the patient's mean pain over the previous 24 hours. Please note that the change from baseline to endpoint in mean pain, i.e. the difference between endpoint mean pain and baseline mean pain, which are defined as follows: * Baseline mean pain is defined as the mean of the last four available ratings of average daily pain (NRPS) in the patient diary performed in the last 7 days before randomisation. * Endpoint mean pain is defined as the mean of the last four available ratings of average daily pain in the patient diary in the last 7 days of the treatment period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
567 participants
Primary outcome timeframe
baseline and 13 weeks
Results posted on
2014-10-29
Participant Flow
First subject enrolled 06 November 2007; Date last subject completed: 19 January 2009. Number of subjects: Planned: 540 subjects (90 in each of the 6 treatment groups). Randomised and treated: 567. Analysed for efficacy (per-protocol): 396 Analysed for safety: 567.
An up to 2-week baseline was followed by a 1-week titration period, an 8-week maintenance period, and a 2-week safety follow-up period. If subjects had a creatinine clearance between 30 and 60 mL/min, they received half of the assigned dose, and subjects with a creatinine clearance below 30 mL/min were not enrolled in this study.
Participant milestones
| Measure |
ESL 1200 mg Once Daily
ESL 1200 mg once daily
Eslicarbazepine acetate : Scored tablets
|
ESL 400 mg Twice-daily
ESL 400 mg twice-daily
Eslicarbazepine acetate : Scored tablets
|
ESL 600 mg Twice Daily
ESL 600 mg twice daily
Eslicarbazepine acetate : Scored tablets
|
ESL 800 mg Once-daily
ESL 800 mg once-daily
Eslicarbazepine acetate : Scored tablets
|
ESL 800 mg Twice Daily
ESL 800 mg twice daily
Eslicarbazepine acetate : Scored tablets
|
Placebo
placebo
Placebo : oral route
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
102
|
94
|
94
|
94
|
90
|
93
|
|
Overall Study
Randomized
|
102
|
94
|
94
|
94
|
90
|
93
|
|
Overall Study
Safety Population
|
102
|
94
|
94
|
94
|
90
|
93
|
|
Overall Study
Per-Protocol
|
69
|
72
|
67
|
68
|
50
|
70
|
|
Overall Study
COMPLETED
|
80
|
75
|
73
|
73
|
60
|
75
|
|
Overall Study
NOT COMPLETED
|
22
|
19
|
21
|
21
|
30
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia
Baseline characteristics by cohort
| Measure |
ESL 1200 mg Once Daily
n=102 Participants
ESL 1200 mg once daily
Eslicarbazepine acetate : Scored tablets
|
ESL 400 mg Twice-daily
n=94 Participants
ESL 400 mg twice-daily
Eslicarbazepine acetate : Scored tablets
|
ESL 600 mg Twice Daily
n=94 Participants
ESL 600 mg twice daily
Eslicarbazepine acetate : Scored tablets
|
ESL 800 mg Once-daily
n=94 Participants
ESL 800 mg once-daily
Eslicarbazepine acetate : Scored tablets
|
ESL 800 mg Twice Daily
n=90 Participants
ESL 800 mg twice daily
Eslicarbazepine acetate : Scored tablets
|
Placebo
n=93 Participants
placebo
Placebo : oral route
|
Total
n=567 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
<=18 years
|
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=10 Participants
|
0 participants
n=115 Participants
|
|
Age, Customized
Between 18 and 65 years
|
34 participants
n=5 Participants
|
36 participants
n=7 Participants
|
35 participants
n=5 Participants
|
37 participants
n=4 Participants
|
30 participants
n=21 Participants
|
38 participants
n=10 Participants
|
210 participants
n=115 Participants
|
|
Age, Customized
>=65 years
|
68 participants
n=5 Participants
|
58 participants
n=7 Participants
|
59 participants
n=5 Participants
|
57 participants
n=4 Participants
|
60 participants
n=21 Participants
|
55 participants
n=10 Participants
|
357 participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
44 Participants
n=10 Participants
|
341 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
226 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: baseline and 13 weeksThe primary efficacy variable will be based upon an 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain, to be recorded in a patient's diary upon awakening each morning. This score should reflect the patient's mean pain over the previous 24 hours. Please note that the change from baseline to endpoint in mean pain, i.e. the difference between endpoint mean pain and baseline mean pain, which are defined as follows: * Baseline mean pain is defined as the mean of the last four available ratings of average daily pain (NRPS) in the patient diary performed in the last 7 days before randomisation. * Endpoint mean pain is defined as the mean of the last four available ratings of average daily pain in the patient diary in the last 7 days of the treatment period.
Outcome measures
| Measure |
ESL 1200 mg Once Daily
n=102 Participants
total daily dose;oral route
|
ESL 400 mg Twice-daily
n=94 Participants
total daily dose;oral route
|
ESL 600 mg Twice Daily
n=94 Participants
total daily dose;oral route
|
ESL 800 mg Once-daily
n=92 Participants
total daily dose;oral route
|
ESL 800 mg Twice Daily
n=87 Participants
total daily dose;oral route
|
Placebo
n=92 Participants
total daily dose;oral route
|
|---|---|---|---|---|---|---|
|
Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain
|
-1.9447 Points
Standard Error 0.2088
|
-1.9786 Points
Standard Error 0.2178
|
-1.6798 Points
Standard Error 0.2179
|
-1.6633 Points
Standard Error 0.2217
|
-2.0834 Points
Standard Error 0.2280
|
-1.5441 Points
Standard Error 0.2197
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 13 weeksDetails of neuropathic pain, as recorded in a subject diary, were used for the primary assessment of analgesic efficacy. Subjects assessed their pain using an 11-point (0 "no pain" to 10 "worst possible pain") NRPS upon awakening each morning and recorded the results in the subject diary. This score reflected the subject's mean pain over the previous 24 hours. Subjects were trained how to record their pain reliably. Investigators were trained in the subject's NRPS use during site initiation visits and at the investigators' meeting.
Outcome measures
| Measure |
ESL 1200 mg Once Daily
n=92 Participants
total daily dose;oral route
|
ESL 400 mg Twice-daily
n=196 Participants
total daily dose;oral route
|
ESL 600 mg Twice Daily
n=87 Participants
total daily dose;oral route
|
ESL 800 mg Once-daily
n=186 Participants
total daily dose;oral route
|
ESL 800 mg Twice Daily
total daily dose;oral route
|
Placebo
total daily dose;oral route
|
|---|---|---|---|---|---|---|
|
Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose
|
-1.5448 Points
Standard Error 0.2196
|
-1.8183 Points
Standard Error 0.1512
|
-2.0854 Points
Standard Error 0.2279
|
-1.8236 Points
Standard Error 0.1565
|
—
|
—
|
Adverse Events
ESL 1200 mg Once Daily
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
ESL 400 mg Twice-daily
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
ESL 600 mg Twice Daily
Serious events: 4 serious events
Other events: 42 other events
Deaths: 0 deaths
ESL 800 mg Once-daily
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
ESL 800 mg Twice Daily
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ESL 1200 mg Once Daily
n=102 participants at risk
ESL 1200 mg once daily
Eslicarbazepine acetate : Scored tablets
|
ESL 400 mg Twice-daily
n=94 participants at risk
ESL 400 mg twice-daily
Eslicarbazepine acetate : Scored tablets
|
ESL 600 mg Twice Daily
n=94 participants at risk
ESL 600 mg twice daily
Eslicarbazepine acetate : Scored tablets
|
ESL 800 mg Once-daily
n=94 participants at risk
ESL 800 mg once-daily
Eslicarbazepine acetate : Scored tablets
|
ESL 800 mg Twice Daily
n=90 participants at risk
ESL 800 mg twice daily
Eslicarbazepine acetate : Scored tablets
|
Placebo
n=93 participants at risk
placebo
Placebo : oral route
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/90 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Infections and infestations
Biliary tract infection
|
0.98%
1/102 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Nervous system disorders
Dizziness
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
Other adverse events
| Measure |
ESL 1200 mg Once Daily
n=102 participants at risk
ESL 1200 mg once daily
Eslicarbazepine acetate : Scored tablets
|
ESL 400 mg Twice-daily
n=94 participants at risk
ESL 400 mg twice-daily
Eslicarbazepine acetate : Scored tablets
|
ESL 600 mg Twice Daily
n=94 participants at risk
ESL 600 mg twice daily
Eslicarbazepine acetate : Scored tablets
|
ESL 800 mg Once-daily
n=94 participants at risk
ESL 800 mg once-daily
Eslicarbazepine acetate : Scored tablets
|
ESL 800 mg Twice Daily
n=90 participants at risk
ESL 800 mg twice daily
Eslicarbazepine acetate : Scored tablets
|
Placebo
n=93 participants at risk
placebo
Placebo : oral route
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
8.8%
9/102 • Number of events 9 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
4.3%
4/94 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
8.5%
8/94 • Number of events 8 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
5.3%
5/94 • Number of events 5 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
12.2%
11/90 • Number of events 11 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/93 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Nervous system disorders
Somnolence
|
5.9%
6/102 • Number of events 6 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
3.2%
3/94 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
11.1%
10/90 • Number of events 10 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/93 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Nervous system disorders
Headache
|
4.9%
5/102 • Number of events 5 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
3.2%
3/94 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
5.3%
5/94 • Number of events 5 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
3.2%
3/94 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
8.9%
8/90 • Number of events 8 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
4.3%
4/93 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Gastrointestinal disorders
Nausea
|
10.8%
11/102 • Number of events 11 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
3.2%
3/94 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
6.4%
6/94 • Number of events 6 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
3.2%
3/94 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
8.9%
8/90 • Number of events 8 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/93 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Ear and labyrinth disorders
Vertigo
|
4.9%
5/102 • Number of events 5 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
3.2%
3/94 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
4.3%
4/94 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
3.2%
3/94 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
3.3%
3/90 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
4.3%
4/93 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
7/102 • Number of events 7 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
4.3%
4/94 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
7.4%
7/94 • Number of events 7 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
4.3%
4/94 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
6.7%
6/90 • Number of events 6 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/93 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.98%
1/102 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
4.3%
4/94 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
4.4%
4/90 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/93 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
General disorders
Asthenia
|
2.9%
3/102 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
3.3%
3/90 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/93 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
General disorders
Fatigue
|
3.9%
4/102 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
6.4%
6/94 • Number of events 6 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
4.3%
4/94 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
4.3%
4/94 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
3.3%
3/90 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/93 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Investigations
GGT increased
|
2.0%
2/102 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
3.2%
3/94 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
3.3%
3/90 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/93 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Nervous system disorders
Balance disorder
|
0.98%
1/102 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/90 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Investigations
Blood pressure increased
|
0.98%
1/102 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/90 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/90 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/93 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/102 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
5.3%
5/94 • Number of events 5 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/90 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
4.3%
4/93 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/90 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/90 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
General disorders
Oedema peripheral
|
0.98%
1/102 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/90 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
2/102 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
4.3%
4/94 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/90 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Psychiatric disorders
Restlessness
|
0.98%
1/102 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/90 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Gastrointestinal disorders
Abdominal pain
|
0.98%
1/102 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/90 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/93 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.98%
1/102 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/90 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/93 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Investigations
Blood creatine phosphokinase increased
|
0.98%
1/102 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/90 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Vascular disorders
Hypertension
|
2.0%
2/102 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
4.3%
4/94 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/90 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/93 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/90 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Infections and infestations
Nasopharyngitis
|
0.98%
1/102 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
3.2%
3/94 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/90 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/93 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
General disorders
Pyrexia
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/90 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Eye disorders
Vision blurred
|
3.9%
4/102 • Number of events 4 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/90 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Blood and lymphatic system disorders
Anaemia
|
0.98%
1/102 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Investigations
Blood triglycerides increased
|
2.9%
3/102 • Number of events 3 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Gastrointestinal disorders
Dyspepsia
|
0.98%
1/102 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.2%
2/93 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
2/102 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
1.1%
1/94 • Number of events 1 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.0%
2/102 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/102 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/94 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
2.1%
2/94 • Number of events 2 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/90 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
0.00%
0/93 • All TEAEs, i.e. those AEs starting after the first dose intake until 2 days after the last dose,have been summarized
|
Additional Information
Head of Clinical Research Section
Bial-Portela & Cª, S.A.
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