Trial Outcomes & Findings for Safety and Efficacy of Alteplase When Administered in Chinese Patients With Acute Ischemic Hemispheric Stroke Where Thrombolysis is Initiated Between 3 and 4.5 Hours After Stroke Onset (NCT NCT02930837)
NCT ID: NCT02930837
Last Updated: 2019-08-05
Results Overview
The percentage of patients with modified Rankin Scale (mRS 0-1) (favourable outcome) response at Visit 5 (Day 90) after stroke onset by face-to-face interview with patient. Modified Rankin Scale (mRS): 0 = no symptom at all, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, and 6 = dead.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
90 days
Results posted on
2019-08-05
Participant Flow
A total of 121 patients were screened from 11 centres across China. Of the screened patients, 1 patient did not meet the study entry criteria. The first patient visit was on 12 December 2016 and the last patient visit was on 11 December 2017.
All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated. Rescue medication was allowed for all patients as required.
Participant milestones
| Measure |
Alteplase (Rt-PA)
Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
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|---|---|
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Overall Study
STARTED
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120
|
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Overall Study
COMPLETED
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108
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|
Overall Study
NOT COMPLETED
|
12
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Reasons for withdrawal
| Measure |
Alteplase (Rt-PA)
Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
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|---|---|
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Overall Study
Adverse Event
|
6
|
|
Overall Study
Lost to Follow-up
|
5
|
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
Treated Set
Baseline characteristics by cohort
| Measure |
Alteplase (Rt-PA)
n=120 Participants
Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
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|---|---|
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Age, Continuous
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61.1 Years
STANDARD_DEVIATION 10.85 • n=5 Participants • Treated Set
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants • Treated Set
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants • Treated Set
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • Treated Set
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
120 Participants
n=5 Participants • Treated Set
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Treated Set
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants • Treated Set
|
|
Race (NIH/OMB)
Asian
|
120 Participants
n=5 Participants • Treated Set
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants • Treated Set
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants • Treated Set
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants • Treated Set
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants • Treated Set
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants • Treated Set
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Baseline NIHSS
|
6.9 Unit on Scale
STANDARD_DEVIATION 4.68 • n=5 Participants • Treated Set
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|
Baseline NIHSS by class
0-3
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36 Participants
n=5 Participants • Treated Set
|
|
Baseline NIHSS by class
4-9
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56 Participants
n=5 Participants • Treated Set
|
|
Baseline NIHSS by class
10-15
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19 Participants
n=5 Participants • Treated Set
|
|
Baseline NIHSS by class
16-20
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7 Participants
n=5 Participants • Treated Set
|
|
Baseline NIHSS by class
>20
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2 Participants
n=5 Participants • Treated Set
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PRIMARY outcome
Timeframe: 90 daysPopulation: Treated Set, worst and last observation carried forward were used for the imputation of efficacy endpoints
The percentage of patients with modified Rankin Scale (mRS 0-1) (favourable outcome) response at Visit 5 (Day 90) after stroke onset by face-to-face interview with patient. Modified Rankin Scale (mRS): 0 = no symptom at all, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, and 6 = dead.
Outcome measures
| Measure |
Alteplase (Rt-PA)
n=120 Participants
Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
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|---|---|
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The Percentage of Patients With Modified Rankin Scale (mRS 0-1) (Favourable Outcome) Response at Day 90 After Stroke Onset by Face-to-face Interview With Patient
No symptom at all
|
42.5 Percentage of patients
|
|
The Percentage of Patients With Modified Rankin Scale (mRS 0-1) (Favourable Outcome) Response at Day 90 After Stroke Onset by Face-to-face Interview With Patient
No sign. disability
|
20.8 Percentage of patients
|
|
The Percentage of Patients With Modified Rankin Scale (mRS 0-1) (Favourable Outcome) Response at Day 90 After Stroke Onset by Face-to-face Interview With Patient
Slight disability
|
8.3 Percentage of patients
|
|
The Percentage of Patients With Modified Rankin Scale (mRS 0-1) (Favourable Outcome) Response at Day 90 After Stroke Onset by Face-to-face Interview With Patient
Moderate disability
|
14.2 Percentage of patients
|
|
The Percentage of Patients With Modified Rankin Scale (mRS 0-1) (Favourable Outcome) Response at Day 90 After Stroke Onset by Face-to-face Interview With Patient
Moderate Severe disability
|
1.7 Percentage of patients
|
|
The Percentage of Patients With Modified Rankin Scale (mRS 0-1) (Favourable Outcome) Response at Day 90 After Stroke Onset by Face-to-face Interview With Patient
Severe disability
|
7.5 Percentage of patients
|
|
The Percentage of Patients With Modified Rankin Scale (mRS 0-1) (Favourable Outcome) Response at Day 90 After Stroke Onset by Face-to-face Interview With Patient
Dead
|
5.0 Percentage of patients
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PRIMARY outcome
Timeframe: 90 daysPopulation: Treated Set
The percentage of patients with symptomatic intracranial haemorrhage (sICH) centrally evaluated by data-monitoring committee (DMC) consultants according to European Cooperative Acute Stroke Study (ECASS) III definition within the whole study period. According to the protocol, sICH (ECASS III criteria) was defined as: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration (defined by an increase in the NIHSS score of 4 or more points), or that led to death and that was identified as the predominant cause of the neurological deterioration. sICH event was firstly evaluated by investigator. The DMC consultants evaluated all the patients with NIHSS score increase of at least 4 any time after treatment (including all fatal patients and sICH events evaluated by investigator). Wilson score confidence interval is presented.
Outcome measures
| Measure |
Alteplase (Rt-PA)
n=120 Participants
Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
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|---|---|
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The Percentage of Patients With Symptomatic Intracranial Haemorrhage (sICH) Centrally Evaluated by Data-monitoring Committee (DMC) Consultants According to European Cooperative Acute Stroke Study (ECASS) III Definition Within the Whole Study Period
Day 0-1
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2.5 Percentage of patients
Interval 0.85 to 7.09
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The Percentage of Patients With Symptomatic Intracranial Haemorrhage (sICH) Centrally Evaluated by Data-monitoring Committee (DMC) Consultants According to European Cooperative Acute Stroke Study (ECASS) III Definition Within the Whole Study Period
Day 2-7
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0.0 Percentage of patients
Not evaluable as 0 patient had event in this time frame
|
|
The Percentage of Patients With Symptomatic Intracranial Haemorrhage (sICH) Centrally Evaluated by Data-monitoring Committee (DMC) Consultants According to European Cooperative Acute Stroke Study (ECASS) III Definition Within the Whole Study Period
Day 8-30
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0.0 Percentage of patients
Not evaluable as 0 patient had event in this time frame
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The Percentage of Patients With Symptomatic Intracranial Haemorrhage (sICH) Centrally Evaluated by Data-monitoring Committee (DMC) Consultants According to European Cooperative Acute Stroke Study (ECASS) III Definition Within the Whole Study Period
Day 31-90
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0.0 Percentage of patients
Not evaluable as 0 patient had event in this time frame
|
|
The Percentage of Patients With Symptomatic Intracranial Haemorrhage (sICH) Centrally Evaluated by Data-monitoring Committee (DMC) Consultants According to European Cooperative Acute Stroke Study (ECASS) III Definition Within the Whole Study Period
Day>90
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0.0 Percentage of patients
Not evaluable as 0 patient had event in this time frame
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SECONDARY outcome
Timeframe: 90 daysPopulation: Treated Set, worst and last observation carried forward were used for the imputation of efficacy endpoints
Percentage of global outcome responder at day 90 if he/she obtains the following results at day 90 for the endpoints mRS score of 0 to 1; Barthel Index score \>= 95; NIHSS score of 0 to 1; Glasgow Outcome Scale score of 1. mRS: 0 = no symptom at all, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, and 6 = dead. NIHSS is composed of 11 items, and for each item a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. Glasgow Outcome Score applies to patients with brain damage allowing the objective assessment of their recovery in five categories: 1 Good Recovery, 2 Moderately Disabled, 3 Severely Disabled, 4 Vegetative State, 5 Dead. Barthel Index score to measure performance in activities of daily living with the scale ranging from 0 to 100. Global outcome response is the intersection of above four respective outcomes.
Outcome measures
| Measure |
Alteplase (Rt-PA)
n=120 Participants
Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
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|---|---|
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The Percentage of Global Outcome Responder at Day 90 if he/She Obtains the Following Results at Day 90 (for All of the 4 Endpoints) mRS Score of 0 to 1; Barthel Index Score >= 95; NIHSS Score of 0 to 1; Glasgow Outcome Scale Score of 1
Global outcome response
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55.0 Percentage of patients
Interval 46.08 to 63.61
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|
The Percentage of Global Outcome Responder at Day 90 if he/She Obtains the Following Results at Day 90 (for All of the 4 Endpoints) mRS Score of 0 to 1; Barthel Index Score >= 95; NIHSS Score of 0 to 1; Glasgow Outcome Scale Score of 1
A response of 0 or 1 on mRS
|
63.3 Percentage of patients
Interval 54.42 to 71.42
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|
The Percentage of Global Outcome Responder at Day 90 if he/She Obtains the Following Results at Day 90 (for All of the 4 Endpoints) mRS Score of 0 to 1; Barthel Index Score >= 95; NIHSS Score of 0 to 1; Glasgow Outcome Scale Score of 1
A response of least 95 on the Barthel index score
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65.8 Percentage of patients
Interval 56.97 to 73.71
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The Percentage of Global Outcome Responder at Day 90 if he/She Obtains the Following Results at Day 90 (for All of the 4 Endpoints) mRS Score of 0 to 1; Barthel Index Score >= 95; NIHSS Score of 0 to 1; Glasgow Outcome Scale Score of 1
A response of 0 or 1 on NIHSS
|
56.7 Percentage of patients
Interval 47.73 to 65.19
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|
The Percentage of Global Outcome Responder at Day 90 if he/She Obtains the Following Results at Day 90 (for All of the 4 Endpoints) mRS Score of 0 to 1; Barthel Index Score >= 95; NIHSS Score of 0 to 1; Glasgow Outcome Scale Score of 1
A Glasgow outcome of 1
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69.2 Percentage of patients
Interval 60.42 to 76.73
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SECONDARY outcome
Timeframe: 90 daysPopulation: Treated Set
Patient survival probability at visit 5 (censoring at day 90). The percentage of patients who died until Day 1, Day 7, Day 30, Day 90.
Outcome measures
| Measure |
Alteplase (Rt-PA)
n=120 Participants
Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
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|---|---|
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Patient Survival Probability at Visit 5 (Censoring at Day 90)
Day 0-1
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0.0 Percentage of patients
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Patient Survival Probability at Visit 5 (Censoring at Day 90)
Day 2-7
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3.3 Percentage of patients
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Patient Survival Probability at Visit 5 (Censoring at Day 90)
Day 8-30
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1.7 Percentage of patients
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|
Patient Survival Probability at Visit 5 (Censoring at Day 90)
Day 31-90
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0.0 Percentage of patients
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SECONDARY outcome
Timeframe: 90 daysPopulation: Treated Set
The percentage of patients with death related to stroke or of neurological causes.
Outcome measures
| Measure |
Alteplase (Rt-PA)
n=120 Participants
Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
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|---|---|
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The Percentage of Patients With Death Related to Stroke or of Neurological Causes
|
4.2 Percentage of patients
Interval 1.79 to 9.38
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SECONDARY outcome
Timeframe: On-treatment period, that is, within 7 days from the start of bolusPopulation: Treated Set
The percentage of patients with severity of adverse events (AEs). The percentage of patients with different categories of AEs are presented.
Outcome measures
| Measure |
Alteplase (Rt-PA)
n=120 Participants
Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
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|---|---|
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The Percentage of Patients With Severity of Adverse Events
Any AE
|
85.8 Percentage of patients
|
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The Percentage of Patients With Severity of Adverse Events
Severe AE
|
20.8 Percentage of patients
|
|
The Percentage of Patients With Severity of Adverse Events
Investigator defined drug-related AEs
|
12.5 Percentage of patients
|
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The Percentage of Patients With Severity of Adverse Events
AEs leading to discontinuation of study drug
|
0.0 Percentage of patients
|
|
The Percentage of Patients With Severity of Adverse Events
Serious AEs
|
10.0 Percentage of patients
|
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The Percentage of Patients With Severity of Adverse Events
Results in death
|
4.2 Percentage of patients
|
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The Percentage of Patients With Severity of Adverse Events
Immediately life threatening
|
3.3 Percentage of patients
|
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The Percentage of Patients With Severity of Adverse Events
Persistent or significant disability/ incapacity
|
1.7 Percentage of patients
|
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The Percentage of Patients With Severity of Adverse Events
Required/prolonged hospitalization
|
5.0 Percentage of patients
|
|
The Percentage of Patients With Severity of Adverse Events
Congenital anomaly/ birth defect
|
0.0 Percentage of patients
|
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The Percentage of Patients With Severity of Adverse Events
Other comparable medical criteria
|
0.0 Percentage of patients
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Treated Set
The percentage of patients with incidence of cerebral herniation and symptomatic edema.
Outcome measures
| Measure |
Alteplase (Rt-PA)
n=120 Participants
Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
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|---|---|
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The Percentage of Patients With Incidence of Cerebral Herniation and Symptomatic Edema
|
4.2 Percentage of patients
Interval 1.79 to 9.38
|
Adverse Events
Alteplase (Rt-PA)
Serious events: 12 serious events
Other events: 72 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Alteplase (Rt-PA)
n=120 participants at risk
Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
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|---|---|
|
Cardiac disorders
Acute left ventricular failure
|
0.83%
1/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
1.7%
2/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Nervous system disorders
Haemorrhage intracranial
|
2.5%
3/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.83%
1/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Nervous system disorders
Cerebral infarction
|
0.83%
1/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Nervous system disorders
Stroke in evolution
|
0.83%
1/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
3/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
Other adverse events
| Measure |
Alteplase (Rt-PA)
n=120 participants at risk
Patients were administered single dose of Alteplase (rt-PA) 0.9 milligram/kilogram (mg/kg) (with an upper limit of 90 milligram (mg)), ten percent of the total dose was administered as a bolus over 1 - 2 minutes. The remaining 90% of the dose was given by continuous intravenous (IV) infusion over 60 minutes if there was no evidence of an allergic reaction within 5 minutes following the administration of the test dose.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
18.3%
22/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
15/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Metabolism and nutrition disorders
Hyperhomocysteinaemia
|
12.5%
15/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Infections and infestations
Lung infection
|
8.3%
10/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
7.5%
9/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Infections and infestations
Pneumonia
|
8.3%
10/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
General disorders
Pyrexia
|
7.5%
9/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Nervous system disorders
Headache
|
7.5%
9/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
5.8%
7/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Nervous system disorders
Cerebral artery stenosis
|
5.8%
7/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
|
Nervous system disorders
Cerebrovascular stenosis
|
5.8%
7/120 • Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days
There is 1 patient died during the post-study period (Day 100) which is not relevant to study medication. But this patient has been counted in this table.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER