Trial Outcomes & Findings for Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4) (NCT NCT00856661)
NCT ID: NCT00856661
Last Updated: 2017-03-16
Results Overview
The mRS is a clinician-rated scale designed to provide a global assessment of the patients dependency after stroke. The scale consists of a single item measuring the patient's function based on the ability to perform daily activities. The patient is rated on a 7-point scale from 0 to 6, where a score of 5 corresponds to severe disability, and 6 to death. Assessment of a pre-stroke mRS score is based on an interview addressing the status of the patient prior to the stroke
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
270 participants
Primary outcome timeframe
Day 90
Results posted on
2017-03-16
Participant Flow
Participant milestones
| Measure |
Desmoteplase
90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
Placebo
Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
135
|
|
Overall Study
Treated
|
126
|
131
|
|
Overall Study
Randomized Not Treated
|
9
|
4
|
|
Overall Study
COMPLETED
|
108
|
106
|
|
Overall Study
NOT COMPLETED
|
27
|
29
|
Reasons for withdrawal
| Measure |
Desmoteplase
90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
Placebo
Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
|---|---|---|
|
Overall Study
Death
|
15
|
18
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Physician Judgement
|
8
|
5
|
Baseline Characteristics
Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)
Baseline characteristics by cohort
| Measure |
Desmoteplase
n=135 Participants
Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
Placebo
n=135 Participants
Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
68.2 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
68.6 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
111 participants
n=5 Participants
|
115 participants
n=7 Participants
|
226 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or african americal
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 90Population: Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.
The mRS is a clinician-rated scale designed to provide a global assessment of the patients dependency after stroke. The scale consists of a single item measuring the patient's function based on the ability to perform daily activities. The patient is rated on a 7-point scale from 0 to 6, where a score of 5 corresponds to severe disability, and 6 to death. Assessment of a pre-stroke mRS score is based on an interview addressing the status of the patient prior to the stroke
Outcome measures
| Measure |
Desmoteplase
n=124 Participants
Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
Placebo
n=128 Participants
Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
|---|---|---|
|
Modified Rankin Scale Score (mRS) (Percentage of Participants With mRS Scores 0-2)
|
41.9 Percentage of participants
|
35.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.
The NIHSS is a clinician-rated, 15-item scale designed to assess the severity of stroke-related neurological deficits: level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect. Each item is rated on a 3-, 4-, or 5-point scale ranging from 0 (normal) to the maximum score (extremely severe symptoms). The total score of the 15 items ranges from 0 to 42, where lower scores indicate less impairment.
Outcome measures
| Measure |
Desmoteplase
n=124 Participants
Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
Placebo
n=128 Participants
Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
|---|---|---|
|
National Institutes of Health Stroke Scale (NIHSS) Score. (Percentage of Participants With NIHSS Scores <=1 or NIHSS Decrease >=8)
|
49.2 Percentage of participants
|
50.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 90Population: Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.
Please see outcomes measure one and two for detailed description of the scales
Outcome measures
| Measure |
Desmoteplase
n=124 Participants
Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
Placebo
n=128 Participants
Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
|---|---|---|
|
Composite of mRS & NIHSS Response (Percentage of Participants With mRS Scores 0-2 and (NIHSS <= 1 or NIHSS Decrease >= 8)
|
32.3 Percentage of participants
|
28.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 90Population: Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.
Please see outcomes measure one for detailed description of the mRS scale
Outcome measures
| Measure |
Desmoteplase
n=124 Participants
Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
Placebo
n=128 Participants
Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
|---|---|---|
|
Modified Ranking Scale Score (Using the Ordinal Scale)
|
3.02 Scores on a scale
Standard Error 0.14
|
3.12 Scores on a scale
Standard Error 0.15
|
Adverse Events
Placebo
Serious events: 56 serious events
Other events: 107 other events
Deaths: 0 deaths
Desmoteplase
Serious events: 61 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=131 participants at risk
Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
Desmoteplase
n=126 participants at risk
Desmoteplase: 90 ug/kg, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Blood and lymphatic system disorders
Deficiency anaemia
|
0.00%
0/131 • baseline to end of study
|
1.6%
2/126 • baseline to end of study
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.76%
1/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Cardiac disorders
Acute myocardial infarction
|
0.76%
1/131 • baseline to end of study
|
1.6%
2/126 • baseline to end of study
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
4/131 • baseline to end of study
|
3.2%
4/126 • baseline to end of study
|
|
Cardiac disorders
Bradycardia
|
0.76%
1/131 • baseline to end of study
|
1.6%
2/126 • baseline to end of study
|
|
Cardiac disorders
Cardiac arrest
|
0.76%
1/131 • baseline to end of study
|
1.6%
2/126 • baseline to end of study
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/131 • baseline to end of study
|
1.6%
2/126 • baseline to end of study
|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
2/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Cardiac disorders
Mitral valve incompetence
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Cardiac disorders
Sick sinus syndrome
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Cardiac disorders
Ventricular tachycardia
|
1.5%
2/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Eye disorders
Pupils unequal
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Gastrointestinal disorders
Abdominal pain
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Gastrointestinal disorders
Haematochezia
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
General disorders
Catheter site phlebitis
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
General disorders
Death
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
General disorders
Multi-organ failure
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Infections and infestations
Bacterial sepsis
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Infections and infestations
Bronchopneumonia
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Infections and infestations
Endocarditis bacterial
|
0.76%
1/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Infections and infestations
Pneumonia
|
0.76%
1/131 • baseline to end of study
|
2.4%
3/126 • baseline to end of study
|
|
Infections and infestations
Pneumonia bacterial
|
3.1%
4/131 • baseline to end of study
|
4.0%
5/126 • baseline to end of study
|
|
Infections and infestations
Pulmonary sepsis
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Infections and infestations
Sepsis
|
1.5%
2/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Infections and infestations
Staphylococcal infection
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/131 • baseline to end of study
|
1.6%
2/126 • baseline to end of study
|
|
Infections and infestations
Urosepsis
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Investigations
Blood culture positive
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Investigations
Haemoglobin decreased
|
3.1%
4/131 • baseline to end of study
|
1.6%
2/126 • baseline to end of study
|
|
Investigations
Nih stroke scale score increased
|
3.1%
4/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Investigations
Platelet count decreased
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Investigations
Respiratory rate increased
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Metabolism and nutrition disorders
Dehydration
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac valve fibroelastoma
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Nervous system disorders
Brain oedema
|
4.6%
6/131 • baseline to end of study
|
2.4%
3/126 • baseline to end of study
|
|
Nervous system disorders
Brain stem stroke
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.76%
1/131 • baseline to end of study
|
1.6%
2/126 • baseline to end of study
|
|
Nervous system disorders
Cerebrovascular accident
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Nervous system disorders
Embolic stroke
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Nervous system disorders
Grand mal convulsion
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.5%
2/131 • baseline to end of study
|
1.6%
2/126 • baseline to end of study
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.00%
0/131 • baseline to end of study
|
3.2%
4/126 • baseline to end of study
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Nervous system disorders
Ischaemic stroke
|
3.8%
5/131 • baseline to end of study
|
2.4%
3/126 • baseline to end of study
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Nervous system disorders
Neurological decompensation
|
1.5%
2/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Nervous system disorders
Stroke in evolution
|
4.6%
6/131 • baseline to end of study
|
7.9%
10/126 • baseline to end of study
|
|
Nervous system disorders
Syncope
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/131 • baseline to end of study
|
2.4%
3/126 • baseline to end of study
|
|
Psychiatric disorders
Agitation
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Psychiatric disorders
Major depression
|
0.00%
0/131 • baseline to end of study
|
1.6%
2/126 • baseline to end of study
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Renal and urinary disorders
Renal failure acute
|
1.5%
2/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.5%
2/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.76%
1/131 • baseline to end of study
|
0.00%
0/126 • baseline to end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
3/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.76%
1/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.76%
1/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/131 • baseline to end of study
|
2.4%
3/126 • baseline to end of study
|
|
Vascular disorders
Deep vein thrombosis
|
0.76%
1/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
|
Vascular disorders
Hypotension
|
0.00%
0/131 • baseline to end of study
|
0.79%
1/126 • baseline to end of study
|
Other adverse events
| Measure |
Placebo
n=131 participants at risk
Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
Desmoteplase
n=126 participants at risk
Desmoteplase: 90 ug/kg, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
9.9%
13/131 • baseline to end of study
|
8.7%
11/126 • baseline to end of study
|
|
Gastrointestinal disorders
Constipation
|
24.4%
32/131 • baseline to end of study
|
23.8%
30/126 • baseline to end of study
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
8/131 • baseline to end of study
|
4.8%
6/126 • baseline to end of study
|
|
Gastrointestinal disorders
Nausea
|
10.7%
14/131 • baseline to end of study
|
9.5%
12/126 • baseline to end of study
|
|
Gastrointestinal disorders
Vomiting
|
9.9%
13/131 • baseline to end of study
|
5.6%
7/126 • baseline to end of study
|
|
General disorders
Oedema peripheral
|
0.76%
1/131 • baseline to end of study
|
8.7%
11/126 • baseline to end of study
|
|
General disorders
Pain
|
5.3%
7/131 • baseline to end of study
|
5.6%
7/126 • baseline to end of study
|
|
General disorders
Pyrexia
|
8.4%
11/131 • baseline to end of study
|
6.3%
8/126 • baseline to end of study
|
|
Infections and infestations
Pneumonia bacterial
|
5.3%
7/131 • baseline to end of study
|
2.4%
3/126 • baseline to end of study
|
|
Infections and infestations
Urinary tract infection
|
3.1%
4/131 • baseline to end of study
|
6.3%
8/126 • baseline to end of study
|
|
Infections and infestations
Urinary tract infection bacterial
|
19.8%
26/131 • baseline to end of study
|
17.5%
22/126 • baseline to end of study
|
|
Injury, poisoning and procedural complications
Fall
|
6.9%
9/131 • baseline to end of study
|
2.4%
3/126 • baseline to end of study
|
|
Investigations
Blood potassium decreased
|
3.1%
4/131 • baseline to end of study
|
6.3%
8/126 • baseline to end of study
|
|
Investigations
Nih stroke scale score increased
|
7.6%
10/131 • baseline to end of study
|
6.3%
8/126 • baseline to end of study
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
9.2%
12/131 • baseline to end of study
|
7.1%
9/126 • baseline to end of study
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.76%
1/131 • baseline to end of study
|
5.6%
7/126 • baseline to end of study
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.3%
20/131 • baseline to end of study
|
14.3%
18/126 • baseline to end of study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
7/131 • baseline to end of study
|
7.1%
9/126 • baseline to end of study
|
|
Nervous system disorders
Headache
|
16.8%
22/131 • baseline to end of study
|
17.5%
22/126 • baseline to end of study
|
|
Nervous system disorders
Stroke in evolution
|
5.3%
7/131 • baseline to end of study
|
5.6%
7/126 • baseline to end of study
|
|
Psychiatric disorders
Anxiety
|
6.1%
8/131 • baseline to end of study
|
8.7%
11/126 • baseline to end of study
|
|
Psychiatric disorders
Depressive symptom
|
9.9%
13/131 • baseline to end of study
|
10.3%
13/126 • baseline to end of study
|
|
Psychiatric disorders
Insomnia
|
8.4%
11/131 • baseline to end of study
|
11.9%
15/126 • baseline to end of study
|
|
Renal and urinary disorders
Haematuria
|
5.3%
7/131 • baseline to end of study
|
4.8%
6/126 • baseline to end of study
|
|
Renal and urinary disorders
Urinary retention
|
6.1%
8/131 • baseline to end of study
|
2.4%
3/126 • baseline to end of study
|
|
Vascular disorders
Hypertension
|
10.7%
14/131 • baseline to end of study
|
12.7%
16/126 • baseline to end of study
|
|
Vascular disorders
Hypotension
|
5.3%
7/131 • baseline to end of study
|
3.2%
4/126 • baseline to end of study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place