Trial Outcomes & Findings for Strategy for Adequate Blood Pressure Lowering in the Patients With Intracranial Atherosclerosis (NCT NCT01104311)
NCT ID: NCT01104311
Last Updated: 2017-03-07
Results Overview
The difference between final ischemic lesions volume and base ischemic lesions of both hemisphere on FLAIR MRI
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
132 participants
Primary outcome timeframe
Screening to 24 weeks
Results posted on
2017-03-07
Participant Flow
The recruitment period of this study was from 07/Apr/2010 to 2/Apr/2014 and there had been recruited at medical clinic.
There were not any significant events and approaches for the overall study following participant enrollment.
Participant milestones
| Measure |
Aggressive BP Lowering
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
|
Modest BP Lowering
Lowering of systolic blood pressure between 130mmHg and 140mmHg
modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
|
Overall Study
COMPLETED
|
56
|
54
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
| Measure |
Aggressive BP Lowering
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
|
Modest BP Lowering
Lowering of systolic blood pressure between 130mmHg and 140mmHg
modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
low compliance
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
2
|
Baseline Characteristics
Strategy for Adequate Blood Pressure Lowering in the Patients With Intracranial Atherosclerosis
Baseline characteristics by cohort
| Measure |
Aggressive BP Lowering
n=66 Participants
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
|
Modest BP Lowering
n=63 Participants
Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
64.8 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
64.2 years
STANDARD_DEVIATION 9.85 • n=5 Participants
|
|
Gender
Female
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Gender
Male
|
41 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening to 24 weeksPopulation: The Number of Participants Analyzed by FAS(Full analysis)Population. FAS Population (Aggressive BP Lowering: 59, Modest BP Lowering: 52)
The difference between final ischemic lesions volume and base ischemic lesions of both hemisphere on FLAIR MRI
Outcome measures
| Measure |
Aggressive BP Lowering
n=59 Participants
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
|
Modest BP Lowering
n=52 Participants
Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
|
|---|---|---|
|
Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI)
Screening
|
11.2 cc
Standard Deviation 24.1
|
10.4 cc
Standard Deviation 19.4
|
|
Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI)
Week 24
|
16.1 cc
Standard Deviation 39.3
|
12.6 cc
Standard Deviation 20.0
|
|
Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI)
Change from Screening to Week 24
|
4.9 cc
Standard Deviation 18.3
|
2.2 cc
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The number of participants are analyzed by FAS population.
the difference between final ischemic lesions volume and base ischemic lesions in the territory of symptomatic intracranial disease on FLAIR MRI
Outcome measures
| Measure |
Aggressive BP Lowering
n=59 Participants
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
|
Modest BP Lowering
n=52 Participants
Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
|
|---|---|---|
|
Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population
Screening
|
10.2 cc
Standard Deviation 22.6
|
9.9 cc
Standard Deviation 19.4
|
|
Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population
Week 24
|
15.0 cc
Standard Deviation 38.6
|
12.0 cc
Standard Deviation 20.0
|
|
Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population
Change from Screening to Week 24
|
4.9 cc
Standard Deviation 18.3
|
2.1 cc
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The Number of Participants are analyzed by ITT (Intent to treat) Population. ITT Population (Aggressive BP Lowering: 66, Modest BP Lowering: 63)
Outcome measures
| Measure |
Aggressive BP Lowering
n=66 Participants
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
|
Modest BP Lowering
n=63 Participants
Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
|
|---|---|---|
|
The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI
Yes
|
10 participants
|
5 participants
|
|
The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI
No
|
49 participants
|
47 participants
|
|
The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI
Missing data
|
7 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The number of participants are analyzed by ITT Population.
Outcome measures
| Measure |
Aggressive BP Lowering
n=66 Participants
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
|
Modest BP Lowering
n=63 Participants
Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
|
|---|---|---|
|
Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population.
|
14 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 24 WeekPopulation: The number of participants are analyzed by ITT population.
Outcome measures
| Measure |
Aggressive BP Lowering
n=66 Participants
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
|
Modest BP Lowering
n=63 Participants
Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
|
|---|---|---|
|
Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population.
|
17 events
|
15 events
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: The number of participants are analyzed by ITT population.
Outcome measures
| Measure |
Aggressive BP Lowering
n=66 Participants
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
|
Modest BP Lowering
n=63 Participants
Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
|
|---|---|---|
|
Number of Participants With Vascular Death From Screening to Week 24 in ITT Population.
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: The number of participants are analyzed by Safety population.
Number of Participants with Adverse Events
Outcome measures
| Measure |
Aggressive BP Lowering
n=65 Participants
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
|
Modest BP Lowering
n=65 Participants
Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
|
|---|---|---|
|
Number of Participants With Adverse Events
Who died
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
With at least on AE
|
51 participants
|
47 participants
|
|
Number of Participants With Adverse Events
With at leat one SAE
|
10 participants
|
8 participants
|
|
Number of Participants With Adverse Events
Withdrawn due to AE
|
1 participants
|
4 participants
|
|
Number of Participants With Adverse Events
With AE due to the treatment
|
5 participants
|
3 participants
|
Adverse Events
Aggressive BP Lowering
Serious events: 10 serious events
Other events: 51 other events
Deaths: 0 deaths
Modest BP Lowering
Serious events: 8 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aggressive BP Lowering
n=65 participants at risk
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level (Safety population: 65)
|
Modest BP Lowering
n=65 participants at risk
Lowering of systolic blood pressure between 130mmHg and 140mmHg
modest blood pressure lowering: adjust the amount and number of antihypertensive drugs (Safety population: 65)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Immune system disorders
INFECTION BACTERIAL
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CARCINOMA
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CARCINOMA
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GENITAL NEOPLASM MALIGNANT MALE
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Renal and urinary disorders
PYELONEPHRITIS
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGIC
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
General disorders
ASTHENIA
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Psychiatric disorders
DELIRIUM
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
HEADACHE
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
NEUROPATHY
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
DIZZINESS
|
3.1%
2/65 • Number of events 2
|
1.5%
1/65
|
|
Nervous system disorders
STUPOR
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Vascular disorders
CEREBRAL INFARCTION
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Vascular disorders
TRANSIENT ISCHAEMIC ATTACK
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
Other adverse events
| Measure |
Aggressive BP Lowering
n=65 participants at risk
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level (Safety population: 65)
|
Modest BP Lowering
n=65 participants at risk
Lowering of systolic blood pressure between 130mmHg and 140mmHg
modest blood pressure lowering: adjust the amount and number of antihypertensive drugs (Safety population: 65)
|
|---|---|---|
|
Hepatobiliary disorders
HEPATIC ENZYMES INCREASED
|
3.1%
2/65 • Number of events 2
|
3.1%
2/65 • Number of events 2
|
|
Hepatobiliary disorders
GALLBLADDER DISORDER
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Hepatobiliary disorders
BILIRUBINAEMIA
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
SKELETAL PAIN
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.2%
4/65 • Number of events 4
|
1.5%
1/65 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
1.5%
1/65 • Number of events 3
|
3.1%
2/65 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
ROTARY CUFF SYNDROME
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Metabolism and nutrition disorders
HYPERLIPAEMIA
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
3.1%
2/65 • Number of events 2
|
1.5%
1/65 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
1.5%
1/65 • Number of events 2
|
0.00%
0/65
|
|
Immune system disorders
ABSCESS
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Immune system disorders
HERPES ZOSTER
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Immune system disorders
INFECTION BACTERIAL
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Blood and lymphatic system disorders
LEUCOPENIA
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Reproductive system and breast disorders
PROSTATIC HYPERPLASIA
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Eye disorders
BLEPHARITIS
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CARCINOMA
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CARCINOMA
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GENITAL NEOPLASM MALIGNANT MALE
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Cardiac disorders
ANGINA PECTORIS
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Vascular disorders
HYPERTENSION AGGRAVATED
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Vascular disorders
HYPOTENSION POSTURAL
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Renal and urinary disorders
RENAL FAILURE CHRONIC
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Renal and urinary disorders
BLADDER CALCULUS
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Renal and urinary disorders
MICTURITION DISORDER
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Renal and urinary disorders
MICTURITION FREQUENCY
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Renal and urinary disorders
PYELONEPHRITIS
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Renal and urinary disorders
NOCTURIA
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Renal and urinary disorders
FACE OEDEMA
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Reproductive system and breast disorders
AZOTAEMIA
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
3.1%
2/65 • Number of events 3
|
0.00%
0/65
|
|
Gastrointestinal disorders
CONSTIPATION
|
6.2%
4/65 • Number of events 4
|
4.6%
3/65 • Number of events 3
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.6%
3/65 • Number of events 3
|
3.1%
2/65 • Number of events 3
|
|
Gastrointestinal disorders
DYSPEPSIA
|
3.1%
2/65 • Number of events 2
|
3.1%
2/65 • Number of events 2
|
|
Gastrointestinal disorders
NAUSEA
|
1.5%
1/65 • Number of events 1
|
3.1%
2/65 • Number of events 3
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
GASTROENTERITIS
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGIC
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
PERIODONTAL DISORDERS
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
PERIODONTAL DESTRUCTION
|
3.1%
2/65 • Number of events 2
|
0.00%
0/65
|
|
Gastrointestinal disorders
MELAENA
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
General disorders
C-REACTIVE PROTEIN INCREASED
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
General disorders
CHEST PAIN
|
4.6%
3/65 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
|
General disorders
OEDEMA PERIPHERAL
|
4.6%
3/65 • Number of events 3
|
6.2%
4/65 • Number of events 4
|
|
General disorders
ASTHENIA
|
1.5%
1/65 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
|
General disorders
ABDOMEN ENLARGED
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
General disorders
SYNCOPE
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
General disorders
ALLERGIC REACTION
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
General disorders
FEVER
|
3.1%
2/65 • Number of events 2
|
1.5%
1/65 • Number of events 1
|
|
General disorders
OEDEMA GENERALISED
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
General disorders
FATIGUE
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
General disorders
AMNESIA
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
General disorders
INSOMNIA
|
3.1%
2/65 • Number of events 2
|
4.6%
3/65 • Number of events 3
|
|
General disorders
ANXIETY
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
General disorders
DELIRIUM
|
3.1%
2/65 • Number of events 2
|
0.00%
0/65
|
|
General disorders
ANOREXIA
|
3.1%
2/65 • Number of events 2
|
1.5%
1/65 • Number of events 1
|
|
General disorders
DEPRESSION
|
6.2%
4/65 • Number of events 4
|
7.7%
5/65 • Number of events 5
|
|
Nervous system disorders
PARAESTHESIA
|
4.6%
3/65 • Number of events 3
|
3.1%
2/65 • Number of events 2
|
|
Nervous system disorders
HYPOAESTHESIA
|
1.5%
1/65 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
|
Nervous system disorders
HEADACHE
|
12.3%
8/65 • Number of events 10
|
18.5%
12/65 • Number of events 13
|
|
Nervous system disorders
PARALYSIS
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
DYSPHONIA
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
GAIT ABNORMAL
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
VISUAL FIELD DEFECT
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
NEUROPATHY
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
APHASIA
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
PTOSIS
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
DIZZINESS
|
13.8%
9/65 • Number of events 9
|
16.9%
11/65 • Number of events 11
|
|
Nervous system disorders
SPEECH DISORDER
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
COGNITIVE DISORDERS
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
DEMENTIA
|
0.00%
0/65
|
4.6%
3/65 • Number of events 3
|
|
Nervous system disorders
APRAXIA
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
STUPOR
|
1.5%
1/65 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
|
Ear and labyrinth disorders
TINNITUS
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Skin and subcutaneous tissue disorders
OTITIS EXTERNA
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DERMATITIS FUNGAL
|
0.00%
0/65
|
1.5%
1/65 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Vascular disorders
CEREBRAL INFARCTION
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Vascular disorders
RENAL ARTERY OCCLUSION
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Vascular disorders
TRANSIENT ISCHAEMIC ATTACK
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Blood and lymphatic system disorders
GINGIVAL BLEEDING
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
|
Blood and lymphatic system disorders
PURPURA
|
3.1%
2/65 • Number of events 3
|
0.00%
0/65
|
|
Respiratory, thoracic and mediastinal disorders
COUGHING
|
4.6%
3/65 • Number of events 3
|
3.1%
2/65 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT INFECTIO
|
3.1%
2/65 • Number of events 2
|
0.00%
0/65
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGITIS
|
1.5%
1/65 • Number of events 1
|
6.2%
4/65 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
1.5%
1/65 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.00%
0/65
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
Additional Information
Sun U. Kwon, MD, PhD, Prof
Asan Medical Center, University of Ulsan
Phone: 82-2-3010-3960
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place