Trial Outcomes & Findings for Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation (NCT NCT01491178)

Last Updated: 2018-01-30

Results Overview

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".

Recruitment status

COMPLETED

Target enrollment

6772 participants

Primary outcome timeframe

Up to 104 weeks from first administration of study drug

Results posted on

2018-01-30

Participant Flow

Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation

6772 subjects were enrolled. Among them, Electronic Case Report Form (eCRF) was not collected for 144 subjects and 185 subjects were excluded because of them not following registration rule, no actual visit or previous treatment experience with Prazaxa, leaving 6443 subjects eligible for study who were enrolled and included in the final study.

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	6443
Overall Study COMPLETED	3649
Overall Study NOT COMPLETED	2794

Reasons for withdrawal

Reasons for withdrawal
Measure	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)
Overall Study Adverse Event	1016
Overall Study Improvement of NVAF	210
Overall Study To conduct invasive treatment	59
Overall Study Lost to follow-up (unknown reason)	287
Overall Study Lost to follow-up (changing hospital)	545
Overall Study To take a contraindication	20
Overall Study Other than specified above	657

Baseline Characteristics

Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With NVAF n=6443 Participants 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)
Age, Continuous	70.9 Years STANDARD_DEVIATION 9.9 • n=93 Participants
Sex: Female, Male Female	2133 Participants n=93 Participants
Sex: Female, Male Male	4310 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 104 weeks from first administration of study drug

Population: 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.

Outcome measures

Outcome measures
Measure	Patients With NVAF n=6443 Participants 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)
Frequency (Percentage) of Participants With Adverse Drug Reactions	28.2 Percentage of participants

SECONDARY outcome

Timeframe: Up to 104 weeks from first administration of study drug

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Patients With NVAF n=6395 Participants 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)
Incidences of Stroke and Systemic Embolism (SEE)	1.27 Number of patients per 100 patient year Interval 1.04 to 1.54

Adverse Events

Patients With NVAF

Serious events: 618 serious events

Other events: 408 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients With NVAF n=6443 participants at risk 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)
Infections and infestations Pneumonia bacterial	0.25% 16/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Pneumonia	0.20% 13/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Cellulitis	0.06% 4/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Sepsis	0.06% 4/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Pyelonephritis	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Appendicitis	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Bronchitis	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Osteomyelitis	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Pulmonary tuberculosis	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Septic shock	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Abscess	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Epididymitis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Oesophageal candidiasis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Peritonitis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Pneumonia mycoplasmal	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Urinary tract infection	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Arteriovenous graft site infection	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Psoas abscess	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Enteritis infectious	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Fungal peritonitis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Infections and infestations Infectious pleural effusion	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.31% 20/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.20% 13/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.14% 9/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.14% 9/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.11% 7/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.08% 5/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.08% 5/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified recurrent	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage IV	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Essential thrombocythaemia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal cancer	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of renal pelvis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal neoplasm	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal cord neoplasm	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour rupture	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Appendix cancer	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Blood and lymphatic system disorders Anaemia	0.09% 6/6443 • Up to 104 weeks from first administration of study drug 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.
Blood and lymphatic system disorders Pancytopenia	0.08% 5/6443 • Up to 104 weeks from first administration of study drug 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.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.06% 4/6443 • Up to 104 weeks from first administration of study drug 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.
Blood and lymphatic system disorders Iron deficiency anaemia	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Metabolism and nutrition disorders Marasmus	0.09% 6/6443 • Up to 104 weeks from first administration of study drug 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.
Metabolism and nutrition disorders Decreased appetite	0.08% 5/6443 • Up to 104 weeks from first administration of study drug 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.
Metabolism and nutrition disorders Dehydration	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Metabolism and nutrition disorders Diabetes mellitus	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Metabolism and nutrition disorders Cachexia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Metabolism and nutrition disorders Hyperammonaemia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Metabolism and nutrition disorders Hypoglycaemia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Metabolism and nutrition disorders Hypokalaemia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Metabolism and nutrition disorders Hyponatraemia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Metabolism and nutrition disorders Feeding disorder	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Psychiatric disorders Schizophrenia	0.06% 4/6443 • Up to 104 weeks from first administration of study drug 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.
Psychiatric disorders Delirium	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Cerebral infarction	0.82% 53/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Embolic stroke	0.22% 14/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Dementia	0.16% 10/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Transient ischaemic attack	0.11% 7/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Cerebral haemorrhage	0.08% 5/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Epilepsy	0.08% 5/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Lacunar infarction	0.08% 5/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Cerebellar infarction	0.06% 4/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Seizure	0.06% 4/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Dementia Alzheimer's type	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Haemorrhage intracranial	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Loss of consciousness	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Syncope	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Ischaemic cerebral infarction	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Thrombotic cerebral infarction	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Brain stem infarction	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Carotid artery stenosis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Cerebral thrombosis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Depressed level of consciousness	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Dyslalia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Hemiplegia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Hypoaesthesia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders IIIrd nerve paralysis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Ruptured cerebral aneurysm	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Sciatica	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Sedation	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Subdural hygroma	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Miller Fisher syndrome	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Clonic convulsion	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Nervous system disorders Embolic cerebral infarction	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Eye disorders Cataract	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Eye disorders Retinal detachment	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Ear and labyrinth disorders Deafness neurosensory	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Cardiac failure	1.1% 73/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Cardiac failure congestive	0.37% 24/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Atrial fibrillation	0.31% 20/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Sinus node dysfunction	0.14% 9/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Acute myocardial infarction	0.12% 8/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Angina pectoris	0.11% 7/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Cardiac failure chronic	0.08% 5/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Angina unstable	0.06% 4/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Atrial flutter	0.06% 4/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Ventricular fibrillation	0.06% 4/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Atrioventricular block complete	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Mitral valve incompetence	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Myocardial infarction	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Tachycardia	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Aortic valve incompetence	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Atrioventricular block second degree	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Cardiac failure acute	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Cardiac tamponade	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Cardio-respiratory arrest	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Atrial thrombosis	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Cardiac valve disease	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Stress cardiomyopathy	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Aortic valve stenosis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Arrhythmia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Atrial tachycardia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Cardiac arrest	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Cardiogenic shock	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Coronary artery disease	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Coronary artery occlusion	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Coronary artery stenosis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Myocardial ischaemia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Nodal arrhythmia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Pericardial haemorrhage	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Prinzmetal angina	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Right ventricular failure	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Supraventricular extrasystoles	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Tachycardia paroxysmal	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Ventricular tachycardia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Intracardiac thrombus	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Cardiac ventricular thrombosis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Cardiac disorders Congestive cardiomyopathy	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Vascular disorders Arterial occlusive disease	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Vascular disorders Deep vein thrombosis	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Vascular disorders Haemorrhage	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Vascular disorders Peripheral arterial occlusive disease	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Vascular disorders Aortic aneurysm	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Vascular disorders Aortic aneurysm rupture	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Vascular disorders Aortic dissection	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Vascular disorders Circulatory collapse	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Vascular disorders Peripheral ischaemia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Vascular disorders Thrombophlebitis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Vascular disorders Shock haemorrhagic	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Vascular disorders Peripheral artery aneurysm	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Vascular disorders Peripheral artery occlusion	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.23% 15/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.06% 4/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Aspiration	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Cough	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.19% 12/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.09% 6/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.09% 6/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Ileus	0.09% 6/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.08% 5/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Large intestine polyp	0.08% 5/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Colitis ischaemic	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Gastric ulcer	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Melaena	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Dyspepsia	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Dysphagia	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Inguinal hernia	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Intestinal obstruction	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Ascites	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Diarrhoea	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Enterocolitis haemorrhagic	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Gastric haemorrhage	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Gastritis haemorrhagic	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Intestinal ischaemia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Large intestinal ulcer	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Peritoneal haemorrhage	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Rectal haemorrhage	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Vomiting	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Oesophageal dysplasia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Large intestinal haemorrhage	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Enterovesical fistula	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Haemorrhagic erosive gastritis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Gastrointestinal disorders Autoimmune pancreatitis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Cholelithiasis	0.06% 4/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Cholangitis acute	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Drug-induced liver injury	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Cholecystitis acute	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Hepatic failure	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Hepatic function abnormal	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Bile duct stone	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Biliary cirrhosis primary	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Biliary colic	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Cholangitis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Cholecystitis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Hepatic cirrhosis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Jaundice cholestatic	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Gallbladder polyp	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Hepatobiliary disorders Hepatic mass	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Skin and subcutaneous tissue disorders Drug eruption	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Musculoskeletal and connective tissue disorders Back pain	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Musculoskeletal and connective tissue disorders Gouty tophus	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Renal and urinary disorders Haematuria	0.06% 4/6443 • Up to 104 weeks from first administration of study drug 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.
Renal and urinary disorders Renal impairment	0.06% 4/6443 • Up to 104 weeks from first administration of study drug 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.
Renal and urinary disorders Acute kidney injury	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Renal and urinary disorders Glomerulonephritis rapidly progressive	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Renal and urinary disorders Hydronephrosis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Renal and urinary disorders Nephrolithiasis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Renal and urinary disorders Renal failure	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Renal and urinary disorders Renal infarct	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Renal and urinary disorders Renal tubular necrosis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Renal and urinary disorders Urogenital haemorrhage	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Renal and urinary disorders Diabetic nephropathy	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Renal and urinary disorders Renal mass	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Renal and urinary disorders Chronic kidney disease	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Renal and urinary disorders Ureterolithiasis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Reproductive system and breast disorders Uterine prolapse	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Congenital, familial and genetic disorders Cerebrovascular arteriovenous malformation	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
General disorders Death	0.17% 11/6443 • Up to 104 weeks from first administration of study drug 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.
General disorders Sudden death	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
General disorders Multiple organ dysfunction syndrome	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
General disorders Asthenia	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
General disorders Condition aggravated	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
General disorders Drowning	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
General disorders Drug interaction	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
General disorders Generalised oedema	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
General disorders Oedema peripheral	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
General disorders Pain	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
General disorders Disuse syndrome	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Investigations Occult blood positive	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Investigations Activated partial thromboplastin time prolonged	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Investigations White blood cell count increased	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Subdural haematoma	0.19% 12/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Fall	0.12% 8/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Femoral neck fracture	0.06% 4/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Contusion	0.05% 3/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Road traffic accident	0.03% 2/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Accident	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Femur fracture	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Fibula fracture	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Injury	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Radius fracture	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Rib fracture	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Spinal compression fracture	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Brain contusion	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Coronary artery restenosis	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Injury, poisoning and procedural complications Heat illness	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Surgical and medical procedures Varicose vein operation	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Surgical and medical procedures Cancer surgery	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.
Surgical and medical procedures Large intestinal polypectomy	0.02% 1/6443 • Up to 104 weeks from first administration of study drug 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.

Other adverse events

Other adverse events
Measure	Patients With NVAF n=6443 participants at risk 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)
Gastrointestinal disorders Dyspepsia	6.3% 408/6443 • Up to 104 weeks from first administration of study drug 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.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

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Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place