Trial Outcomes & Findings for J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation (NCT NCT00659581)
NCT ID: NCT00659581
Last Updated: 2016-08-25
Results Overview
Recruitment status
COMPLETED
Target enrollment
21471 participants
Primary outcome timeframe
3 years after initiation of treatment
Results posted on
2016-08-25
Participant Flow
In the survey, 21,433 patients were enrolled. The data of 439 patients have not reported after the registration, and 551 patients were not observed after the registration: 38 entry violation, 24 contract violation, 493 no office visit after initial prescription and 9 undefined study medication (the numbers were overlapping).
Participant milestones
| Measure |
Telmisartan
|
|---|---|
|
Overall Study
STARTED
|
20994
|
|
Overall Study
COMPLETED
|
12412
|
|
Overall Study
NOT COMPLETED
|
8582
|
Reasons for withdrawal
| Measure |
Telmisartan
|
|---|---|
|
Overall Study
Adverse Event
|
1006
|
|
Overall Study
Lack of Efficacy
|
1183
|
|
Overall Study
Other
|
6393
|
Baseline Characteristics
J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation
Baseline characteristics by cohort
| Measure |
Telmisartan
n=20443 Participants
|
|---|---|
|
Age, Continuous
|
64.6 years old
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10278 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10165 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 years after initiation of treatmentPopulation: All of observed 20,443 patients were included as intention to treat set
Outcome measures
| Measure |
Telmisartan
n=20443 Participants
|
|---|---|
|
Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events
Number of patients with CeV and CaV events
|
479 Number of participants
|
|
Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events
Number of patients with no CeV and CaV events
|
19964 Number of participants
|
SECONDARY outcome
Timeframe: initiation and 6 monthsPopulation: The 2503 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 6 months were excluded.
Outcome measures
| Measure |
Telmisartan
n=17940 Participants
|
|---|---|
|
Change From Baseline in Systolic Blood Pressure at 6 Months
|
-20.6 mmHg
Standard Deviation 19.9
|
SECONDARY outcome
Timeframe: initiation and 6 monthsPopulation: The 2506 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 6 months were excluded.
Outcome measures
| Measure |
Telmisartan
n=17937 Participants
|
|---|---|
|
Change From Baseline in Diastolic Blood Pressure at 6 Months
|
-10.3 mmHg
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: initiation and 12 monthsPopulation: The 4400 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 12 months were excluded.
Outcome measures
| Measure |
Telmisartan
n=16043 Participants
|
|---|---|
|
Change From Baseline in Systolic Blood Pressure at 12 Months
|
-22.2 mmHg
Standard Deviation 19.9
|
SECONDARY outcome
Timeframe: initiation and 12 monthsPopulation: The 4400 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 12 months were excluded.
Outcome measures
| Measure |
Telmisartan
n=16043 Participants
|
|---|---|
|
Change From Baseline in Diastolic Blood Pressure at 12 Months
|
-11.3 mmHg
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: initiation and 24 monthsPopulation: The 6544 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 24 months were excluded.
Outcome measures
| Measure |
Telmisartan
n=13899 Participants
|
|---|---|
|
Change From Baseline in Systolic Blood Pressure at 24 Months
|
-23.9 mmHg
Standard Deviation 20.2
|
SECONDARY outcome
Timeframe: initiation and 24 monthsPopulation: The 6544 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 24 months were excluded.
Outcome measures
| Measure |
Telmisartan
n=13899 Participants
|
|---|---|
|
Change From Baseline in Diastolic Blood Pressure at 24 Months
|
-12.3 mmHg
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: initiation and 36 monthsPopulation: The 8267 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 36 months were excluded.
Outcome measures
| Measure |
Telmisartan
n=12176 Participants
|
|---|---|
|
Change From Baseline in Systolic Blood Pressure at 36 Months
|
-25.0 mmHg
Standard Deviation 19.9
|
SECONDARY outcome
Timeframe: initiation and 36 monthsPopulation: The 8270 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 36 months were excluded.
Outcome measures
| Measure |
Telmisartan
n=12173 Participants
|
|---|---|
|
Change From Baseline in Diastolic Blood Pressure at 36 Months
|
-13.1 mmHg
Standard Deviation 13.0
|
Adverse Events
Telmisartan
Serious events: 1058 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telmisartan
n=20443 participants at risk
|
|---|---|
|
Infections and infestations
Pneumonia bacterial
|
0.05%
11/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Pulmonary tuberculoma
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Pyelonephritis
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Pyometra
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Sepsis
|
0.04%
9/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Septic shock
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Blood and lymphatic system disorders
Anaemia
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Blood and lymphatic system disorders
Blood disorder
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Blood and lymphatic system disorders
Erythropenia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Acute myocardial infarction
|
0.06%
12/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Angina pectoris
|
0.44%
90/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Angina unstable
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Aortic valve incompetence
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Atrial fibrillation
|
0.04%
8/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Atrioventricular block complete
|
0.02%
4/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Bradycardia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Cardiac failure
|
0.37%
76/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Cardiac failure acute
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Cardiac failure chronic
|
0.02%
4/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Cardiac failure congestive
|
0.02%
5/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Cardiac sarcoidosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Mitral valve incompetence
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
58/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Myocardial rupture
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Prinzmetal angina
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Sick sinus syndrome
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Tachycardia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Ventricular fibrillation
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Cardiac disorders
Ventricular tachycardia
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Endocrine disorders
Primary hyperaldosteronism
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Eye disorders
Cataract
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Eye disorders
Retinal detachment
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Ascites
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Colonic polyp
|
0.02%
5/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.02%
5/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Ileus
|
0.02%
5/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.02%
4/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Melaena
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Mesenteric occlusion
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Pancreatitis
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Peritonitis
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Rectal lesion
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
General disorders
Chest pain
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
General disorders
Condition aggravated
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
General disorders
Death
|
0.17%
35/20443 • From signing the informed consent through the end of study
|
|
General disorders
Drowning
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
General disorders
Gait disturbance
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
General disorders
General physical health deterioration
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
General disorders
Multi-organ failure
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
General disorders
Oedema peripheral
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Hepatobiliary disorders
Bile duct stone
|
0.02%
4/20443 • From signing the informed consent through the end of study
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.02%
4/20443 • From signing the informed consent through the end of study
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Hepatobiliary disorders
Liver disorder
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Appendicitis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Arteriosclerotic gangrene
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Bronchopneumonia
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Cellulitis
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Dacryocystitis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Endocarditis
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Gallbladder abscess
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Gangrene
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Gastroenteritis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Hepatitis C
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Herpes zoster
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Influenza
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Liver abscess
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Lobar pneumonia
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Meningitis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Otitis media
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Peritoneal tuberculosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Pneumonia
|
0.08%
16/20443 • From signing the informed consent through the end of study
|
|
Infections and infestations
Urinary tract infection
|
0.02%
4/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Fall
|
0.05%
11/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.05%
10/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.02%
5/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Fracture
|
0.02%
5/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Internal injury
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.02%
5/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.03%
6/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Uterine rupture
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Investigations
Blood creatinine increased
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Investigations
Blood pressure decreased
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Investigations
Blood pressure increased
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Investigations
Glucose urine present
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Investigations
Haemoglobin decreased
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Investigations
Protein urine present
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Investigations
Weight increased
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Metabolism and nutrition disorders
Dehydration
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.05%
11/20443 • From signing the informed consent through the end of study
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.08%
16/20443 • From signing the informed consent through the end of study
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Metabolism and nutrition disorders
Marasmus
|
0.02%
5/20443 • From signing the informed consent through the end of study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Musculoskeletal and connective tissue disorders
Collagen disorder
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adult T-cell lymphoma/leukaemia
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.02%
5/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.02%
4/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.02%
5/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.02%
4/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.03%
7/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.21%
42/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer recurrent
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.03%
7/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant recurrent
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.13%
26/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.16%
32/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.02%
4/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.04%
8/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma recurrent
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.05%
11/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma recurrent
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer stage unspecified
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma malignant
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.03%
7/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.03%
6/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.02%
4/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal cancer
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma malignant
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Amnesia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Carotid artery stenosis
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.15%
31/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Cerebral infarction
|
0.83%
169/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Convulsion
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Dementia
|
0.03%
6/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Dizziness
|
0.01%
3/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Dyskinesia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Embolic stroke
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Loss of consciousness
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Monoplegia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Quadriplegia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.06%
13/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Transient ischaemic attack
|
0.11%
22/20443 • From signing the informed consent through the end of study
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Psychiatric disorders
Alcoholism
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Psychiatric disorders
Completed suicide
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Psychiatric disorders
Delirium
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Psychiatric disorders
Depression
|
0.02%
5/20443 • From signing the informed consent through the end of study
|
|
Psychiatric disorders
Eating disorder
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Calculus ureteric
|
0.02%
4/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.06%
13/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Lupus nephritis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Mesangioproliferative glomerulonephritis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.02%
4/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Renal failure
|
0.04%
9/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Renal failure acute
|
0.02%
4/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Renal failure chronic
|
0.11%
23/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Renal impairment
|
0.03%
6/20443 • From signing the informed consent through the end of study
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.02%
4/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Caplanas syndrome
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.04%
9/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.04%
9/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.03%
6/20443 • From signing the informed consent through the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Surgical and medical procedures
Aortic anastomosis
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Surgical and medical procedures
Dialysis device insertion
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Surgical and medical procedures
Orthopedic procedure
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Surgical and medical procedures
Vascular graft
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Aneurysm
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Aortic aneurysm
|
0.03%
6/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Aortic dissection
|
0.02%
5/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Aortic occlusion
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Aortic rupture
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.03%
7/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Deep vein thrombosis
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Haemorrhage
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Hypotension
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Intermittent claudication
|
0.01%
2/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Shock
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
1/20443 • From signing the informed consent through the end of study
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place