Post-Marketing Surveillance of Prazaxa® on the Long-term... | NCT01491178

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Patients with NVAF			Drug: Prazaxa

Name	Type	Description	Arm Group Labels	Other Names
Prazaxa	Drug	Dabigatran etexilate	Patients with NVAF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency (Percentage) of Participants With Adverse Drug Reactions	Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as "Related", "Probably related", or "Cannot be denied".	Up to 104 weeks from first administration of study drug

Secondary Outcomes

Measure	Description	Time Frame
Incidences of Stroke and Systemic Embolism (SEE)	Incidence rate of Stroke and SEE (number of patients per 100 patient year) with 95% confidence interval (CI) is reported. Stroke and SEE were recorded as adverse events (AEs) of special interest. Exact Poisson confidence intervals are presented for incidence rate.	Up to 104 weeks from first administration of study drug

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site 1		Abashiri, Hokkaido			Japan
Boehringer Ingelheim Investigational Site 287

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30746608	Derived	Koretsune Y, Kusakawa K, Harada KH, Koizumi A, Uchiyama S, Atarashi H, Okumura K, Yasaka M, Yamashita T, Taniguchi A, Fukaya T, Inoue H; for J-dabigatran surveillance and JAPAF study investigators. Characteristics of Japanese Patients with Nonvalvular Atrial Fibrillation on Anticoagulant Treatment: A Descriptive Analysis of J-dabigatran Surveillance and JAPAF Study. Cardiol Ther. 2019 Jun;8(1):43-54. doi: 10.1007/s40119-019-0129-2. Epub 2019 Feb 11.
27092197

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Patients With NVAF	Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Safety set: This patient set includes all patients who received treatment of Prazaxa® Capsules except those who were found not following registration rule, no actual visit, previous treatment experience with Prazaxa.

Arm/Group Information

ID	Title	Description
BG000	Patients With NVAF	Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG00028.2

Secondary

Incidences of Stroke and Systemic Embolism (SEE)

Incidence rate of Stroke and SEE (number of patients per 100 patient year) with 95% confidence interval (CI) is reported. Stroke and SEE were recorded as adverse events (AEs) of special interest. Exact Poisson confidence intervals are presented for incidence rate.

Effectiveness set: This analysis set included all patients who received treatment of Prazaxa® Capsules except those who were found not following registration rule, no actual visit, previous treatment experience with Prazaxa, contraindication and / or who did not suffer from NVAF.

Posted

Number

95% Confidence Interval

Number of patients per 100 patient year

Up to 104 weeks from first administration of study drug

ID	Title	Description
OG000	Patients With NVAF	Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Patients With NVAF	Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d)			618	6,443	408	6,443

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia bacterial	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00016 affected6,443 at risk
Pneumonia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00013 affected6,443 at risk
Cellulitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0004 affected6,443 at risk
Sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0004 affected6,443 at risk
Pyelonephritis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Appendicitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Bronchitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Osteomyelitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Septic shock	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Epididymitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Peritonitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Psoas abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Enteritis infectious	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Fungal peritonitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00020 affected6,443 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG00013 affected6,443 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0009 affected6,443 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0009 affected6,443 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0007 affected6,443 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0005 affected6,443 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0005 affected6,443 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Lung carcinoma cell type unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Colon cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Essential thrombocythaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Hypopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Lung carcinoma cell type unspecified stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Malignant neoplasm of renal pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Pharyngeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Spinal cord neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Tumour rupture	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Appendix cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0006 affected6,443 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected6,443 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected6,443 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Marasmus	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0006 affected6,443 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected6,443 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Feeding disorder	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Schizophrenia	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected6,443 at risk
Delirium	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Cerebral infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG00053 affected6,443 at risk
Embolic stroke	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG00014 affected6,443 at risk
Dementia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG00010 affected6,443 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0007 affected6,443 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected6,443 at risk
Epilepsy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected6,443 at risk
Lacunar infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected6,443 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected6,443 at risk
Seizure	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected6,443 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Loss of consciousness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Syncope	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Thrombotic cerebral infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Brain stem infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Cerebral thrombosis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Dyslalia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Hemiplegia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
IIIrd nerve paralysis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Ruptured cerebral aneurysm	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Sciatica	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Sedation	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Subdural hygroma	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Miller Fisher syndrome	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Clonic convulsion	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Embolic cerebral infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Cataract	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Retinal detachment	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Cardiac failure	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG00073 affected6,443 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG00024 affected6,443 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG00020 affected6,443 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0009 affected6,443 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0008 affected6,443 at risk
Angina pectoris	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0007 affected6,443 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected6,443 at risk
Angina unstable	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected6,443 at risk
Atrial flutter	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected6,443 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected6,443 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Myocardial infarction	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Tachycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Arrhythmia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Cardiac arrest	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Coronary artery disease	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Prinzmetal angina	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Right ventricular failure	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Tachycardia paroxysmal	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Haemorrhage	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Aortic aneurysm	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Aortic dissection	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Circulatory collapse	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Thrombophlebitis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG00015 affected6,443 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected6,443 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG00012 affected6,443 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0006 affected6,443 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0006 affected6,443 at risk
Ileus	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0006 affected6,443 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected6,443 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected6,443 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Melaena	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Ascites	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Oesophageal dysplasia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Autoimmune pancreatitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected6,443 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Biliary cirrhosis primary	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Hepatic mass	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Gouty tophus	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Haematuria	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected6,443 at risk
Renal impairment	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected6,443 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Glomerulonephritis rapidly progressive	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Renal failure	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Renal infarct	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Urogenital haemorrhage	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Renal mass	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Cerebrovascular arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Death	General disorders	MedDRA 19.1	Systematic Assessment	EG00011 affected6,443 at risk
Sudden death	General disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Asthenia	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Condition aggravated	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Drowning	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Drug interaction	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Generalised oedema	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Oedema peripheral	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Disuse syndrome	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Occult blood positive	Investigations	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
White blood cell count increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG00012 affected6,443 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0008 affected6,443 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0004 affected6,443 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0003 affected6,443 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 affected6,443 at risk
Accident	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Heat illness	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Varicose vein operation	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Cancer surgery	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk
Large intestinal polypectomy	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0001 affected6,443 at risk

The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.

Certain Agreements

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms