Trial Outcomes & Findings for Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN) (NCT NCT00592904)
NCT ID: NCT00592904
Last Updated: 2016-01-21
Results Overview
Mean change from baseline to open-label study endpoint and other study visits in SF-MPQ scores sensory and affective). SF-MPQ was completed to assess intensity of pain over the past 48 days for all 15 descriptors: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting,tiring-exhausting, sickening, fear-causing, punishing-cruel. Each descriptor was scored by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0-45); higher scores indicated higher intensity of pain.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
262 participants
Primary outcome timeframe
Baseline and Week 48
Results posted on
2016-01-21
Participant Flow
Participant milestones
| Measure |
Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PDN: Prior Treatment of Perampanel
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PHN: Prior Treatment of Perampanel
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
57
|
148
|
27
|
30
|
|
Overall Study
COMPLETED
|
32
|
93
|
10
|
19
|
|
Overall Study
NOT COMPLETED
|
25
|
55
|
17
|
11
|
Reasons for withdrawal
| Measure |
Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PDN: Prior Treatment of Perampanel
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PHN: Prior Treatment of Perampanel
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
15
|
25
|
13
|
5
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
16
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
7
|
2
|
3
|
|
Overall Study
Physician Decision
|
0
|
3
|
1
|
0
|
|
Overall Study
Other
|
3
|
3
|
0
|
0
|
Baseline Characteristics
Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)
Baseline characteristics by cohort
| Measure |
Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo
n=57 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PDN: Prior Treatment of Perampanel
n=148 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo
n=27 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PHN: Prior Treatment of Perampanel
n=30 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
Total
n=262 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<65
|
40 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
155 Participants
n=21 Participants
|
|
Age, Customized
≥65
|
17 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
149 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
48 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
225 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 48Population: Intent-to-Treat (ITT) Population: All enrolled subjects (starting at Visit 1) who took at least 1 dose of study drug and had at least 1 efficacy assessment in this trial comprised the ITT Population. All efficacy analyses were performed on the ITT Population. One subject had a protocol violation after consenting and was withdrawn from treatment.
Mean change from baseline to open-label study endpoint and other study visits in SF-MPQ scores sensory and affective). SF-MPQ was completed to assess intensity of pain over the past 48 days for all 15 descriptors: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting,tiring-exhausting, sickening, fear-causing, punishing-cruel. Each descriptor was scored by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0-45); higher scores indicated higher intensity of pain.
Outcome measures
| Measure |
Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo
n=57 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PDN: Prior Treatment of Perampanel
n=147 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo
n=27 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PHN: Prior Treatment of Perampanel
n=30 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.
|
-10.5 Scores on a Scale
Standard Deviation 8.41
|
-8.1 Scores on a Scale
Standard Deviation 9.65
|
-9.0 Scores on a Scale
Standard Deviation 6.72
|
-9.8 Scores on a Scale
Standard Deviation 10.19
|
PRIMARY outcome
Timeframe: Baseline and Week 48Population: ITT Population
SF-MPQ VAS consists of a line 0 to 100 millimeters (mm) in length; range is 0 (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.
Outcome measures
| Measure |
Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo
n=57 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PDN: Prior Treatment of Perampanel
n=147 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo
n=27 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PHN: Prior Treatment of Perampanel
n=30 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
|---|---|---|---|---|
|
Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48.
|
-43.1 Scores on a Scale
Standard Deviation 23.17
|
-33.7 Scores on a Scale
Standard Deviation 24.49
|
-35.9 Scores on a Scale
Standard Deviation 24.55
|
-35.4 Scores on a Scale
Standard Deviation 27.66
|
PRIMARY outcome
Timeframe: Baseline and Week 48Population: ITT Population
Mean change from baseline in SF-MPQ (CPI) at study endpoint. Affective score ranges from 0-5. Higher scores indicate more severe pain (0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible, 5=excrutiating).
Outcome measures
| Measure |
Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo
n=57 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PDN: Prior Treatment of Perampanel
n=147 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo
n=27 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PHN: Prior Treatment of Perampanel
n=30 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
|---|---|---|---|---|
|
Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48
|
-0.9 Scores on a Scale
Standard Deviation 0.71
|
-1.0 Scores on a Scale
Standard Deviation 1.24
|
-1.1 Scores on a Scale
Standard Deviation 0.57
|
-1.3 Scores on a Scale
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.
The PGIC asked subjects to evaluate the change in their overall status compared with the start of open-label treatment on a scale ranging from 1 (very much improved) to 7 (very much worse). \[Please note high withdrawl rate during study\].
Outcome measures
| Measure |
Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo
n=40 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PDN: Prior Treatment of Perampanel
n=122 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo
n=21 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PHN: Prior Treatment of Perampanel
n=27 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
|---|---|---|---|---|
|
Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)
Very much improved (1)
|
8 Participants
|
22 Participants
|
5 Participants
|
6 Participants
|
|
Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)
Much improved (2)
|
16 Participants
|
33 Participants
|
3 Participants
|
9 Participants
|
|
Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)
Minimally improved (3)
|
12 Participants
|
39 Participants
|
4 Participants
|
7 Participants
|
|
Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)
No change (4)
|
3 Participants
|
13 Participants
|
3 Participants
|
5 Participants
|
|
Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)
Minimally worse (5)
|
0 Participants
|
12 Participants
|
2 Participants
|
0 Participants
|
|
Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)
Much worse (6)
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)
Very much worse (7)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: ITT Population
Mean change from baseline in SF-36 Item Health Survey Scores at study endpoint. Each component on the SF-36 Item Health Survey is scored from 0-100 with higher scores reflecting better subject status.
Outcome measures
| Measure |
Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo
n=57 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PDN: Prior Treatment of Perampanel
n=147 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo
n=27 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
PHN: Prior Treatment of Perampanel
n=30 Participants
All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT
Physical Component Score
|
5.48 Scores on a Scale
Standard Deviation 8.14
|
5.14 Scores on a Scale
Standard Deviation 9.36
|
1.72 Scores on a Scale
Standard Deviation 8.27
|
2.18 Scores on a Scale
Standard Deviation 9.30
|
|
Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT
Mental Component Score
|
0.40 Scores on a Scale
Standard Deviation 8.90
|
-2.32 Scores on a Scale
Standard Deviation 10.62
|
-1.53 Scores on a Scale
Standard Deviation 10.77
|
-3.12 Scores on a Scale
Standard Deviation 12.44
|
Adverse Events
Placebo
Serious events: 11 serious events
Other events: 72 other events
Deaths: 0 deaths
Perampanel
Serious events: 25 serious events
Other events: 132 other events
Deaths: 0 deaths
Painful Diabetic Neuropathy
Serious events: 31 serious events
Other events: 160 other events
Deaths: 0 deaths
Post Herpetic Neuralgia
Serious events: 5 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=84 participants at risk
The participants who had previously received placebo during the double-blind study.
|
Perampanel
n=178 participants at risk
The participants that had previously received perampanel during the double-blind study.
|
Painful Diabetic Neuropathy
n=205 participants at risk
The participants that were being treated for PDN in the double-blind study and received either placebo or perampanel.
|
Post Herpetic Neuralgia
n=57 participants at risk
The participants that were being treated for PHN in the double-blind study and received either placebo or perampanel.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Cardiac disorders
Arrhythmia
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.1%
2/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
3.5%
2/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Cardiac disorders
Atrial flutter
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Cardiac disorders
Bradycardia
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Cardiac disorders
Cor pulmonale
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.1%
2/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.98%
2/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.1%
2/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.98%
2/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.1%
2/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.8%
1/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Infections and infestations
Sepsis
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.8%
1/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.8%
1/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.8%
1/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.8%
1/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Investigations
Blood glucose increased
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.98%
2/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Nervous system disorders
Dementia
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Nervous system disorders
Syncope
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Psychiatric disorders
Mental status changes
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Vascular disorders
Hypertension
|
0.00%
0/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.56%
1/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.49%
1/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.00%
0/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
Other adverse events
| Measure |
Placebo
n=84 participants at risk
The participants who had previously received placebo during the double-blind study.
|
Perampanel
n=178 participants at risk
The participants that had previously received perampanel during the double-blind study.
|
Painful Diabetic Neuropathy
n=205 participants at risk
The participants that were being treated for PDN in the double-blind study and received either placebo or perampanel.
|
Post Herpetic Neuralgia
n=57 participants at risk
The participants that were being treated for PHN in the double-blind study and received either placebo or perampanel.
|
|---|---|---|---|---|
|
General disorders
Oedema peripheral
|
6.0%
5/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
7.3%
13/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
7.8%
16/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
3.5%
2/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Infections and infestations
Bronchitis
|
3.6%
3/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
3.9%
7/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
3.4%
7/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.3%
3/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
3/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
4.5%
8/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
3.9%
8/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.3%
3/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
8/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
6.7%
12/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
7.8%
16/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
7.0%
4/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Ear and labyrinth disorders
Vertigo
|
4.8%
4/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
6.2%
11/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
6.8%
14/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.8%
1/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
6/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
8.4%
15/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
8.3%
17/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
7.0%
4/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
6/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
3.4%
6/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.4%
11/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.8%
1/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
General disorders
Fatigue
|
11.9%
10/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.1%
9/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
6.8%
14/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
8.8%
5/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
General disorders
Gait disturbance
|
7.1%
6/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.1%
9/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.9%
12/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.3%
3/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
General disorders
Irritability
|
6.0%
5/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
2.2%
4/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
3.4%
7/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
3.5%
2/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
6/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.1%
9/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.9%
12/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.3%
3/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Injury, poisoning and procedural complications
Fall
|
11.9%
10/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
8.4%
15/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
10.2%
21/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
7.0%
4/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Investigations
Blood glucose increased
|
6.0%
5/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.1%
2/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
2.9%
6/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.8%
1/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
5/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
7.3%
13/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
6.8%
14/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
7.0%
4/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
4/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
2.2%
4/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
2.4%
5/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.3%
3/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.4%
2/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
6.2%
11/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.9%
12/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.8%
1/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
2/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
2.8%
5/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
2.0%
4/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.3%
3/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
5/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.7%
3/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
2.4%
5/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.3%
3/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Nervous system disorders
Ataxia
|
4.8%
4/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
2.2%
4/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.5%
3/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
8.8%
5/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Nervous system disorders
Balance disorder
|
7.1%
6/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
6.7%
12/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.9%
12/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
10.5%
6/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Nervous system disorders
Dizziness
|
42.9%
36/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
35.4%
63/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
37.1%
76/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
40.4%
23/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Nervous system disorders
Dysarthria
|
8.3%
7/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.1%
9/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.9%
12/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
7.0%
4/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Nervous system disorders
Headache
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
4.5%
8/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
2.9%
6/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.3%
3/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Nervous system disorders
Somnolence
|
17.9%
15/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
19.7%
35/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
18.5%
38/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
21.1%
12/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Psychiatric disorders
Confusional state
|
4.8%
4/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
2.8%
5/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
2.0%
4/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
8.8%
5/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Psychiatric disorders
Insomnia
|
1.2%
1/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
3.4%
6/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
2.0%
4/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.3%
3/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
2/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
2.2%
4/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
0.98%
2/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
7.0%
4/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
|
Vascular disorders
Hypertension
|
6.0%
5/84 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
3.9%
7/178 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
5.4%
11/205 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
1.8%
1/57 • Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.
A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.
|
Additional Information
Eisai Inc.
Eisai Call Center
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place