Trial Outcomes & Findings for Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke (NCT NCT01955707)
NCT ID: NCT01955707
Last Updated: 2016-07-01
Results Overview
Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 5 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
161 participants
Primary outcome timeframe
Baseline, Day 5
Results posted on
2016-07-01
Participant Flow
Participant milestones
| Measure |
Placebo
A single intravenous (IV) injection of placebo
|
Natalizumab
300 mg single IV injection of natalizumab
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
79
|
|
Overall Study
Withdrew Prior to Dosing
|
0
|
1
|
|
Overall Study
Dosed
|
82
|
78
|
|
Overall Study
Received Total Volume of Study Drug
|
82
|
77
|
|
Overall Study
COMPLETED
|
62
|
57
|
|
Overall Study
NOT COMPLETED
|
20
|
22
|
Reasons for withdrawal
| Measure |
Placebo
A single intravenous (IV) injection of placebo
|
Natalizumab
300 mg single IV injection of natalizumab
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Death
|
13
|
14
|
|
Overall Study
Other
|
4
|
2
|
Baseline Characteristics
Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke
Baseline characteristics by cohort
| Measure |
Placebo
n=82 Participants
A single IV injection of placebo
|
Natalizumab
n=79 Participants
300 mg single IV injection of natalizumab
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 11.83 • n=93 Participants
|
70.3 years
STANDARD_DEVIATION 13.34 • n=4 Participants
|
71.0 years
STANDARD_DEVIATION 12.57 • n=27 Participants
|
|
Age, Customized
</= 39 years
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Age, Customized
40 to 59 years
|
13 participants
n=93 Participants
|
11 participants
n=4 Participants
|
24 participants
n=27 Participants
|
|
Age, Customized
60 to 79 years
|
41 participants
n=93 Participants
|
45 participants
n=4 Participants
|
86 participants
n=27 Participants
|
|
Age, Customized
>/= 80 years
|
26 participants
n=93 Participants
|
20 participants
n=4 Participants
|
46 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 5Population: Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.
Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 5 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.
Outcome measures
| Measure |
Placebo
n=73 Participants
A single IV injection of placebo
|
Natalizumab
n=69 Participants
300 mg single IV injection of natalizumab
|
|---|---|---|
|
Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])
|
2.17 mL
Interval 1.6 to 3.17
|
2.37 mL
Interval 1.51 to 2.91
|
SECONDARY outcome
Timeframe: Baseline, 24 hrsPopulation: Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.
Relative growth of infarct volume from Baseline (relative growth = FLAIR at 24 hours divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.
Outcome measures
| Measure |
Placebo
n=74 Participants
A single IV injection of placebo
|
Natalizumab
n=69 Participants
300 mg single IV injection of natalizumab
|
|---|---|---|
|
Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR)
|
1.73 mL
Interval 1.33 to 2.15
|
1.95 mL
Interval 1.36 to 2.2
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.
Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 30 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.
Outcome measures
| Measure |
Placebo
n=66 Participants
A single IV injection of placebo
|
Natalizumab
n=55 Participants
300 mg single IV injection of natalizumab
|
|---|---|---|
|
Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR)
|
1.27 mL
Interval 0.9 to 1.88
|
1.25 mL
Interval 0.78 to 1.93
|
SECONDARY outcome
Timeframe: 24 hours, Day 5Population: Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.
Relative growth of infarct volume from 24 hours (relative growth = FLAIR at Day 5 divided by FLAIR at 24 hours). Geometric mean calculated as the exponential of the mean log relative growth.
Outcome measures
| Measure |
Placebo
n=70 Participants
A single IV injection of placebo
|
Natalizumab
n=65 Participants
300 mg single IV injection of natalizumab
|
|---|---|---|
|
Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR)
|
1.27 mL
Interval 1.11 to 1.37
|
1.25 mL
Interval 1.11 to 1.42
|
SECONDARY outcome
Timeframe: 24 hours, Day 30Population: Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.
Relative growth in infarct volume from Baseline (relative growth = FLAIR Day 30 divided by FLAIR at 24 hours ). Geometric mean calculated as the exponential of the mean log relative growth.
Outcome measures
| Measure |
Placebo
n=62 Participants
A single IV injection of placebo
|
Natalizumab
n=53 Participants
300 mg single IV injection of natalizumab
|
|---|---|---|
|
Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR)
|
0.75 mL
Interval 0.62 to 1.03
|
0.72 mL
Interval 0.56 to 1.09
|
SECONDARY outcome
Timeframe: Day 5, Day 30Population: Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.
Relative growth of infarct volume from Day 5 (relative growth = FLAIR at Day 30 divided by FLAIR at Day 5). Geometric mean calculated as the exponential of the mean log relative growth.
Outcome measures
| Measure |
Placebo
n=64 Participants
A single IV injection of placebo
|
Natalizumab
n=54 Participants
300 mg single IV injection of natalizumab
|
|---|---|---|
|
Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR)
|
0.60 mL
Interval 0.52 to 0.79
|
0.59 mL
Interval 0.42 to 0.81
|
SECONDARY outcome
Timeframe: Baseline, 24 hours, Day 5, Day 30, Day 90Population: Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment); n=participants with assessments at Baseline and given time point.
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Scores for the NIHSS range from 0 to 42, with 0 representing no symptoms and 42 representing death.
Outcome measures
| Measure |
Placebo
n=82 Participants
A single IV injection of placebo
|
Natalizumab
n=77 Participants
300 mg single IV injection of natalizumab
|
|---|---|---|
|
Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90
Change at 24 hours; n=82, 77
|
-1.5 units on a scale
Standard Deviation 3.96
|
-1.5 units on a scale
Standard Deviation 5.10
|
|
Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90
Change at Day 5; n=79, 72
|
-3.3 units on a scale
Standard Deviation 5.31
|
-2.1 units on a scale
Standard Deviation 6.24
|
|
Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90
Change at Day 30; n=73, 62
|
-5.7 units on a scale
Standard Deviation 5.22
|
-4.9 units on a scale
Standard Deviation 5.73
|
|
Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90
Change at Day 90; n=62, 56
|
-7.3 units on a scale
Standard Deviation 3.95
|
-6.8 units on a scale
Standard Deviation 5.78
|
SECONDARY outcome
Timeframe: Day 5, Day 30, and Day 90Population: Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment), using imputed data; n=number of participants with an assessment at given time point.
The mRS measures independence, rather than neurologic function, with specific tasks pre- and post-stroke, respectively. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. The distribution of mRS scores was summarized at each timepoint. An excellent outcome on the mRS was defined as a score of 0 or 1, while a good outcome was defined as a score of 0, 1, or 2.
Outcome measures
| Measure |
Placebo
n=82 Participants
A single IV injection of placebo
|
Natalizumab
n=77 Participants
300 mg single IV injection of natalizumab
|
|---|---|---|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 30: Score 0; n=81, 72
|
0 participants
|
5 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 5: Score 0; n=82, 76
|
0 participants
|
2 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 5: Score 1; n=82, 76
|
3 participants
|
2 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 5: Score 2; n=82, 76
|
10 participants
|
11 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 5: Score 3; n=82, 76
|
13 participants
|
11 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 5: Score 4; n=82, 76
|
25 participants
|
16 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 5: Score 5; n=82, 76
|
29 participants
|
31 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 5: Score 6; n=82, 76
|
2 participants
|
3 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 30: Score 1; n=81, 72
|
7 participants
|
8 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 30: Score 2; n=81, 72
|
14 participants
|
8 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 30: Score 3; n=81, 72
|
17 participants
|
17 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 30: Score 4; n=81, 72
|
22 participants
|
14 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 30: Score 5; n=81, 72
|
13 participants
|
11 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 30: Score 6; n=81, 72
|
8 participants
|
9 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 90: Score 0; n=78, 72
|
4 participants
|
8 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 90: Score 1; n=78, 72
|
12 participants
|
10 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 90: Score 2; n=78, 72
|
12 participants
|
10 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 90: Score 3; n=78, 72
|
15 participants
|
13 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 90: Score 4; n=78, 72
|
14 participants
|
11 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 90: Score 5; n=78, 72
|
8 participants
|
6 participants
|
|
Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90
Day 90: Score 6; n=78, 72
|
13 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Day 5, Day 30, and Day 90Population: Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment); n=participants with assessment at given time point.
The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility, and can be used to determine a baseline level of functioning and to monitor change in activities of daily living over time. The scores for each of the items are summed to create a total score up to a potential of 100, with higher scores representing a greater level of independence.
Outcome measures
| Measure |
Placebo
n=82 Participants
A single IV injection of placebo
|
Natalizumab
n=77 Participants
300 mg single IV injection of natalizumab
|
|---|---|---|
|
Barthel Index at Day 5, Day 30, and Day 90
Day 5; n=78, 73
|
35.0 units on a scale
Interval 0.0 to 100.0
|
30.0 units on a scale
Interval 0.0 to 100.0
|
|
Barthel Index at Day 5, Day 30, and Day 90
Day 30; n=73, 60
|
70.0 units on a scale
Interval 0.0 to 100.0
|
80.0 units on a scale
Interval 0.0 to 100.0
|
|
Barthel Index at Day 5, Day 30, and Day 90
Day 90; n=61, 55
|
80.0 units on a scale
Interval 0.0 to 100.0
|
95.0 units on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to Day 90 ± 5 daysPopulation: Safety population (all participants who were randomized and received any portion of the infusion of study treatment).
AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as severe, moderate, or mild, and related or not related to study treatment.
Outcome measures
| Measure |
Placebo
n=82 Participants
A single IV injection of placebo
|
Natalizumab
n=78 Participants
300 mg single IV injection of natalizumab
|
|---|---|---|
|
Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with an event
|
81 participants
|
77 participants
|
|
Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with a moderate or severe event
|
60 participants
|
53 participants
|
|
Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with a severe event
|
27 participants
|
22 participants
|
|
Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with a related event
|
7 participants
|
6 participants
|
|
Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with a serious event
|
38 participants
|
36 participants
|
|
Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants discontinuing due to an event
|
0 participants
|
0 participants
|
|
Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants withdrawing from study due to event
|
2 participants
|
1 participants
|
Adverse Events
Placebo
Serious events: 38 serious events
Other events: 75 other events
Deaths: 0 deaths
Natalizumab
Serious events: 36 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=82 participants at risk
A single IV injection of placebo
|
Natalizumab
n=78 participants at risk
300 mg single IV injection of natalizumab
|
|---|---|---|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Cardiac disorders
Cardiac failure
|
2.4%
2/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Cardiac disorders
Cardiac failure chronic
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Cardiac disorders
Myocardial infarction
|
2.4%
2/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Cardiac disorders
Pulseless electrical activity
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Endocrine disorders
Toxic nodular goitre
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
General disorders
Death
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
General disorders
Device dislocation
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
General disorders
Multi-organ failure
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
2.6%
2/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Infections and infestations
Diverticulitis
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Infections and infestations
Endocarditis
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Infections and infestations
Influenza
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Infections and infestations
Pneumonia
|
2.4%
2/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
3.8%
3/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Infections and infestations
Septic shock
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Infections and infestations
Urinary tract infection
|
2.4%
2/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.4%
2/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Basilar artery thrombosis
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Brain midline shift
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Brain oedema
|
2.4%
2/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Carotid artery stenosis
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
3.8%
3/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Cerebral infarction
|
2.4%
2/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
5.1%
4/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Cerebral ischaemia
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.4%
2/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
2.6%
2/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
2.6%
2/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Dementia
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Dementia alzheimer's type
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Generalised non-convulsive epilepsy
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
3.7%
3/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
5.1%
4/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Headache
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Ischaemic stroke
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Neurological decompensation
|
2.4%
2/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Partial seizures
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Stroke in evolution
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
2.6%
2/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Subdural hygroma
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Vocal cord paralysis
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Psychiatric disorders
Aggression
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Psychiatric disorders
Delirium
|
2.4%
2/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Renal and urinary disorders
Renal failure
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Renal and urinary disorders
Renal failure chronic
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
2.6%
2/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Surgical and medical procedures
Endarterectomy
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Vascular disorders
Peripheral embolism
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Vascular disorders
Peripheral ischaemia
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
0.00%
0/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
Other adverse events
| Measure |
Placebo
n=82 participants at risk
A single IV injection of placebo
|
Natalizumab
n=78 participants at risk
300 mg single IV injection of natalizumab
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
4/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
10.3%
8/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
6.4%
5/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
2/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
5.1%
4/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.1%
5/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
5.1%
4/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.4%
2/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
5.1%
4/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.7%
3/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
7.7%
6/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.7%
3/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
11.5%
9/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.2%
10/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
12.8%
10/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.9%
4/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
10.3%
8/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Cardiac disorders
Atrial fibrillation
|
12.2%
10/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
9.0%
7/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Cardiac disorders
Bradycardia
|
6.1%
5/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
1.3%
1/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Cardiac disorders
Tachycardia
|
6.1%
5/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
3.8%
3/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Gastrointestinal disorders
Constipation
|
28.0%
23/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
30.8%
24/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Gastrointestinal disorders
Nausea
|
13.4%
11/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
11.5%
9/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
18.3%
15/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
6.4%
5/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
General disorders
Pain
|
7.3%
6/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
11.5%
9/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
General disorders
Pyrexia
|
31.7%
26/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
41.0%
32/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Infections and infestations
Pneumonia
|
7.3%
6/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
12.8%
10/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Infections and infestations
Respiratory tract infection
|
11.0%
9/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
5.1%
4/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Infections and infestations
Urinary tract infection
|
15.9%
13/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
24.4%
19/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.1%
5/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
3.8%
3/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
6/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
5.1%
4/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.9%
4/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
5.1%
4/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Brain oedema
|
3.7%
3/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
7.7%
6/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
5.1%
4/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
25.6%
21/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
23.1%
18/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Headache
|
23.2%
19/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
16.7%
13/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Neurological decompensation
|
2.4%
2/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
5.1%
4/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Nervous system disorders
Somnolence
|
3.7%
3/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
5.1%
4/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Psychiatric disorders
Agitation
|
3.7%
3/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
14.1%
11/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Psychiatric disorders
Anxiety
|
1.2%
1/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
7.7%
6/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Psychiatric disorders
Depression
|
15.9%
13/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
6.4%
5/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Psychiatric disorders
Insomnia
|
15.9%
13/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
9.0%
7/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Psychiatric disorders
Post stroke depression
|
2.4%
2/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
5.1%
4/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Psychiatric disorders
Sleep disorder
|
8.5%
7/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
10.3%
8/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Renal and urinary disorders
Urinary retention
|
7.3%
6/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
6.4%
5/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Vascular disorders
Hypertension
|
12.2%
10/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
19.2%
15/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
|
Vascular disorders
Hypotension
|
14.6%
12/82 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
2.6%
2/78 • From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER