Trial Outcomes & Findings for Japanese Pradaxa PMS, Long Term (NCT NCT03175198)

Participant milestones
Measure	Patients With Nonvalvular Atrial Fibrillation (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) for a treatment duration of 52 weeks.
Overall Study STARTED	5565
Overall Study Safety Set 1	5436
Overall Study COMPLETED	3238
Overall Study NOT COMPLETED	2327

Reasons for withdrawal
Measure	Patients With Nonvalvular Atrial Fibrillation (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) for a treatment duration of 52 weeks.
Overall Study Adverse Event	480
Overall Study No actual visit	120
Overall Study Registration rule not followed	4
Overall Study Patients received Prazaxa treatment before	5
Overall Study Other personal reason	509
Overall Study To take a contraindication/careful administration drug	8
Overall Study Lost to follow-up (changing hospital)	373
Overall Study Lost to follow-up (unknown reason)	146
Overall Study To conduct invasive treatment of operation	53
Overall Study Improvement of nonvalvular atrial fibrillation	629

Baseline characteristics by cohort
Measure	Patients With Nonvalvular Atrial Fibrillation (NVAF) n=5436 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) for a treatment duration of 52 weeks.
Age, Continuous	69.8 years STANDARD_DEVIATION 11.1 • n=5436 Participants
Sex: Female, Male Female	1624 Participants n=5436 Participants
Sex: Female, Male Male	3812 Participants n=5436 Participants

Outcome measures
Measure	Patients With Nonvalvular Atrial Fibrillation (NVAF) n=5436 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) for a treatment duration of 52 weeks.
Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)	10.69 Percentage of participants

Serious adverse events
Measure	Patients With Nonvalvular Atrial Fibrillation (NVAF) n=5436 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) for a treatment duration of 52 weeks.
Infections and infestations Pneumonia bacterial	0.09% 5/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Pneumonia	0.07% 4/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Cellulitis	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Pyelonephritis acute	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Bacteraemia	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Empyema	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Endocarditis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Endophthalmitis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Gangrene	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Influenza	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Necrotising fasciitis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Pseudomembranous colitis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Pyelitis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Sepsis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Tuberculous pleurisy	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Arthritis bacterial	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Arthritis infective	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Infective spondylitis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Bacterial prostatitis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Infectious pleural effusion	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Infections and infestations Complicated appendicitis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.11% 6/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.09% 5/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.09% 5/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiocentric lymphoma	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric adenoma	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal neoplasm	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasm	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Soft tissue neoplasm	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Blood and lymphatic system disorders Anaemia	0.07% 4/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Endocrine disorders Basedow's disease	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Metabolism and nutrition disorders Diabetes mellitus	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Metabolism and nutrition disorders Decreased appetite	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Metabolism and nutrition disorders Hypokalaemia	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Metabolism and nutrition disorders Hyponatraemia	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Metabolism and nutrition disorders Marasmus	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Psychiatric disorders Delirium	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Cerebral infarction	0.57% 31/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Embolic cerebral infarction	0.11% 6/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Epilepsy	0.09% 5/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Haemorrhagic cerebral infarction	0.07% 4/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Cerebral artery embolism	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Cerebral haemorrhage	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Embolic stroke	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Cerebrovascular accident	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Dementia	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Transient ischaemic attack	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Lacunar infarction	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Altered state of consciousness	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Brain stem infarction	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Cerebral atrophy	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Depressed level of consciousness	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Dizziness	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Facial paralysis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Myelopathy	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Neuralgia	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Paralysis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Paraparesis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Status epilepticus	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Subarachnoid haemorrhage	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Syncope	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Visual field defect	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Carotid artery occlusion	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Carotid artery dissection	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Nervous system disorders Cerebral disorder	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Eye disorders Glaucoma	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Eye disorders Cataract	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Ear and labyrinth disorders Vertigo	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Cardiac failure	1.2% 64/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Atrial fibrillation	0.52% 28/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Cardiac failure congestive	0.24% 13/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Angina pectoris	0.18% 10/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Sinus node dysfunction	0.15% 8/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Acute myocardial infarction	0.09% 5/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Cardiac tamponade	0.09% 5/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Cardiac failure acute	0.07% 4/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Atrial thrombosis	0.07% 4/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Atrioventricular block complete	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Cardiac failure chronic	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Pericardial effusion	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Aortic valve stenosis	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Atrial flutter	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Myocardial infarction	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Pericardial haemorrhage	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Ventricular tachycardia	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Aortic valve incompetence	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Arteriosclerosis coronary artery	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Bundle branch block left	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Cardiomegaly	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Coronary artery stenosis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Mitral valve incompetence	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Sinus arrest	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Supraventricular tachycardia	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Tachycardia paroxysmal	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Ventricular fibrillation	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Cardiac disorders Stress cardiomyopathy	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Vascular disorders Peripheral arterial occlusive disease	0.09% 5/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Vascular disorders Circulatory collapse	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Vascular disorders Deep vein thrombosis	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Vascular disorders Arterial occlusive disease	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Vascular disorders Embolism arterial	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Vascular disorders Haemorrhagic infarction	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Vascular disorders Aortic aneurysm	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Vascular disorders Aortic aneurysm rupture	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Vascular disorders Aortic dissection	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Vascular disorders Arteriovenous fistula	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Vascular disorders Shock haemorrhagic	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Vascular disorders Arterial stenosis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Vascular disorders Atheroembolism	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.11% 6/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Asthma	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Bronchial haemorrhage	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.11% 6/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Melaena	0.07% 4/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Mechanical ileus	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Abdominal pain	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Pancreatitis acute	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Rectal ulcer	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Large intestine polyp	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Abdominal distension	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Abdominal pain upper	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Diarrhoea	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Dyspepsia	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Dysphagia	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Gastric dilatation	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Haemorrhoids	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Ileus	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Incarcerated inguinal hernia	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Inguinal hernia	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Oesophageal ulcer	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Gastric hypomotility	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Large intestinal haemorrhage	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Gastrointestinal disorders Large intestinal stenosis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Hepatobiliary disorders Cholelithiasis	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Hepatobiliary disorders Acute hepatic failure	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Hepatobiliary disorders Cholangitis	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Hepatobiliary disorders Cholangitis acute	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Hepatobiliary disorders Drug-induced liver injury	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Hepatobiliary disorders Bile duct stone	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Hepatobiliary disorders Cholecystitis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Hepatobiliary disorders Hepatic cirrhosis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Hepatobiliary disorders Hepatic failure	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Hepatobiliary disorders Hepatitis fulminant	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Hepatobiliary disorders Jaundice cholestatic	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Hepatobiliary disorders Primary biliary cholangitis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Skin and subcutaneous tissue disorders Dermatomyositis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Skin and subcutaneous tissue disorders Eczema nummular	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Musculoskeletal and connective tissue disorders Arthritis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Musculoskeletal and connective tissue disorders Pain in extremity	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Renal and urinary disorders Acute kidney injury	0.11% 6/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Renal and urinary disorders Renal impairment	0.06% 3/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Renal and urinary disorders Renal failure	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Renal and urinary disorders Urinary retention	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Renal and urinary disorders Calculus urinary	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Renal and urinary disorders Haematuria	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Renal and urinary disorders Nephrolithiasis	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Renal and urinary disorders Renal infarct	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Renal and urinary disorders Postrenal failure	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Renal and urinary disorders Chronic kidney disease	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Reproductive system and breast disorders Prostatic haemorrhage	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
General disorders Death	0.11% 6/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
General disorders Chest discomfort	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
General disorders Sudden death	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
General disorders Chest pain	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
General disorders Generalised oedema	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
General disorders Malaise	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
General disorders Oedema peripheral	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
General disorders Pyrexia	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
General disorders Oedema due to cardiac disease	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
General disorders Multiple organ dysfunction syndrome	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Investigations Heart rate decreased	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Investigations Weight increased	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Subdural haematoma	0.09% 5/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Fall	0.07% 4/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Pelvic fracture	0.04% 2/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Clavicle fracture	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Femoral neck fracture	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Femur fracture	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Fractured sacrum	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Humerus fracture	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Rib fracture	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Spinal compression fracture	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Contusion	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Incision site haemorrhage	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Vascular procedure complication	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Procedural haemorrhage	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Injury, poisoning and procedural complications Meniscus injury	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Surgical and medical procedures Cardiac pacemaker insertion	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Surgical and medical procedures Finger amputation	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Surgical and medical procedures Mitral valve replacement	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Surgical and medical procedures Valvuloplasty cardiac	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Surgical and medical procedures Cardiac ablation	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.
Surgical and medical procedures Cardiac operation	0.02% 1/5436 • From baseline till the last administration + 6 days. Up to 364 days. Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Pneumonia bacterial

0.09%

5/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Pneumonia

0.07%

4/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Cellulitis

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Pyelonephritis acute

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Bacteraemia

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Empyema

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Endocarditis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Endophthalmitis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Gangrene

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Influenza

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Necrotising fasciitis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Pseudomembranous colitis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Pyelitis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Sepsis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Tuberculous pleurisy

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Arthritis bacterial

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Arthritis infective

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Infective spondylitis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Bacterial prostatitis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Infectious pleural effusion

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Infections and infestations

Complicated appendicitis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm malignant

0.11%

6/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer

0.09%

5/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastric cancer

0.09%

5/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic carcinoma

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal cancer

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to liver

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to lymph nodes

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Plasma cell myeloma

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon adenoma

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant neoplasm progression

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to peritoneum

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small intestine carcinoma

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatocellular carcinoma

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Angiocentric lymphoma

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bile duct cancer

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder cancer

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bone cancer

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cholangiocarcinoma

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Chronic lymphocytic leukaemia

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to bone

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Myelodysplastic syndrome

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectosigmoid cancer

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of lung

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Uterine cancer

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neuroendocrine carcinoma

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastric adenoma

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Abdominal neoplasm

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastrointestinal neoplasm

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Soft tissue neoplasm

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Blood and lymphatic system disorders

Anaemia

0.07%

4/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Blood and lymphatic system disorders

Disseminated intravascular coagulation

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Endocrine disorders

Basedow's disease

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Metabolism and nutrition disorders

Diabetes mellitus

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Metabolism and nutrition disorders

Decreased appetite

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Metabolism and nutrition disorders

Hypokalaemia

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Metabolism and nutrition disorders

Hyponatraemia

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Metabolism and nutrition disorders

Marasmus

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Psychiatric disorders

Delirium

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Cerebral infarction

0.57%

31/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Embolic cerebral infarction

0.11%

6/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Epilepsy

0.09%

5/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Haemorrhagic cerebral infarction

0.07%

4/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Cerebral artery embolism

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Cerebral haemorrhage

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Embolic stroke

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Cerebrovascular accident

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Dementia

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Transient ischaemic attack

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Lacunar infarction

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Altered state of consciousness

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Brain stem infarction

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Cerebral atrophy

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Depressed level of consciousness

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Dizziness

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Facial paralysis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Myelopathy

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Neuralgia

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Paralysis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Paraparesis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Status epilepticus

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Subarachnoid haemorrhage

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Syncope

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Visual field defect

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Carotid artery occlusion

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Carotid artery dissection

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Nervous system disorders

Cerebral disorder

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Eye disorders

Glaucoma

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Eye disorders

Cataract

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Ear and labyrinth disorders

Vertigo

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Cardiac failure

1.2%

64/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Atrial fibrillation

0.52%

28/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Cardiac failure congestive

0.24%

13/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Angina pectoris

0.18%

10/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Sinus node dysfunction

0.15%

8/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Acute myocardial infarction

0.09%

5/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Cardiac tamponade

0.09%

5/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Cardiac failure acute

0.07%

4/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Atrial thrombosis

0.07%

4/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Atrioventricular block complete

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Cardiac failure chronic

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Pericardial effusion

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Aortic valve stenosis

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Atrial flutter

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Myocardial infarction

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Pericardial haemorrhage

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Ventricular tachycardia

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Aortic valve incompetence

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Arteriosclerosis coronary artery

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Bundle branch block left

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Cardiomegaly

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Coronary artery stenosis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Mitral valve incompetence

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Sinus arrest

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Supraventricular tachycardia

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Tachycardia paroxysmal

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Ventricular fibrillation

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Cardiac disorders

Stress cardiomyopathy

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Vascular disorders

Peripheral arterial occlusive disease

0.09%

5/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Vascular disorders

Circulatory collapse

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Vascular disorders

Deep vein thrombosis

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Vascular disorders

Arterial occlusive disease

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Vascular disorders

Embolism arterial

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Vascular disorders

Haemorrhagic infarction

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Vascular disorders

Aortic aneurysm

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Vascular disorders

Aortic aneurysm rupture

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Vascular disorders

Aortic dissection

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Vascular disorders

Arteriovenous fistula

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Vascular disorders

Shock haemorrhagic

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Vascular disorders

Arterial stenosis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Vascular disorders

Atheroembolism

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Interstitial lung disease

0.11%

6/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Dyspnoea

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Epistaxis

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Pleural effusion

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Pneumonia aspiration

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Respiratory failure

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Asthma

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Haemoptysis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Pneumothorax

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Respiratory arrest

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Obstructive airways disorder

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Bronchial haemorrhage

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Respiratory, thoracic and mediastinal disorders

Organising pneumonia

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Gastrointestinal haemorrhage

0.11%

6/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Melaena

0.07%

4/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Diverticulum intestinal haemorrhagic

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Mechanical ileus

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Abdominal pain

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Pancreatitis acute

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Rectal ulcer

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Upper gastrointestinal haemorrhage

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Large intestine polyp

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Abdominal distension

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Abdominal pain upper

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Diarrhoea

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Dyspepsia

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Dysphagia

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Gastric dilatation

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Gastric ulcer haemorrhage

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Haemorrhoids

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Ileus

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Incarcerated inguinal hernia

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Inguinal hernia

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Oesophageal ulcer

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Lower gastrointestinal haemorrhage

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Gastric hypomotility

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Large intestinal haemorrhage

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Haemorrhoidal haemorrhage

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Gastrointestinal disorders

Large intestinal stenosis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Hepatobiliary disorders

Cholelithiasis

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Hepatobiliary disorders

Acute hepatic failure

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Hepatobiliary disorders

Cholangitis

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Hepatobiliary disorders

Cholangitis acute

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Hepatobiliary disorders

Drug-induced liver injury

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Hepatobiliary disorders

Bile duct stone

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Hepatobiliary disorders

Cholecystitis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Hepatobiliary disorders

Hepatic cirrhosis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Hepatobiliary disorders

Hepatic failure

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Hepatobiliary disorders

Hepatitis fulminant

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Hepatobiliary disorders

Jaundice cholestatic

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Hepatobiliary disorders

Primary biliary cholangitis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Skin and subcutaneous tissue disorders

Dermatomyositis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Skin and subcutaneous tissue disorders

Eczema nummular

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Skin and subcutaneous tissue disorders

Stevens-Johnson syndrome

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Musculoskeletal and connective tissue disorders

Arthritis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Musculoskeletal and connective tissue disorders

Osteoarthritis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Musculoskeletal and connective tissue disorders

Pain in extremity

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Musculoskeletal and connective tissue disorders

Haematoma muscle

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Renal and urinary disorders

Acute kidney injury

0.11%

6/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Renal and urinary disorders

Renal impairment

0.06%

3/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Renal and urinary disorders

Renal failure

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Renal and urinary disorders

Urinary retention

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Renal and urinary disorders

Calculus urinary

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Renal and urinary disorders

Haematuria

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Renal and urinary disorders

Nephrolithiasis

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Renal and urinary disorders

Renal infarct

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Renal and urinary disorders

Postrenal failure

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Renal and urinary disorders

Chronic kidney disease

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Reproductive system and breast disorders

Benign prostatic hyperplasia

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Reproductive system and breast disorders

Prostatic haemorrhage

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

General disorders

Death

0.11%

6/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

General disorders

Chest discomfort

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

General disorders

Sudden death

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

General disorders

Chest pain

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

General disorders

Generalised oedema

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

General disorders

Malaise

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

General disorders

Oedema peripheral

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

General disorders

Pyrexia

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

General disorders

Oedema due to cardiac disease

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

General disorders

Multiple organ dysfunction syndrome

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Investigations

Heart rate decreased

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Investigations

Weight increased

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Subdural haematoma

0.09%

5/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Fall

0.07%

4/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Pelvic fracture

0.04%

2/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Clavicle fracture

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Femoral neck fracture

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Femur fracture

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Fractured sacrum

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Humerus fracture

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Rib fracture

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Spinal compression fracture

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Contusion

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Post procedural haemorrhage

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Incision site haemorrhage

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Vascular procedure complication

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Traumatic intracranial haemorrhage

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Procedural haemorrhage

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Injury, poisoning and procedural complications

Meniscus injury

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Surgical and medical procedures

Cardiac pacemaker insertion

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Surgical and medical procedures

Finger amputation

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Surgical and medical procedures

Mitral valve replacement

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Surgical and medical procedures

Valvuloplasty cardiac

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Surgical and medical procedures

Cardiac ablation

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Surgical and medical procedures

Cardiac operation

0.02%

1/5436 • From baseline till the last administration + 6 days. Up to 364 days.

Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups.

Trial Outcomes & Findings for Japanese Pradaxa PMS, Long Term (NCT NCT03175198)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Outcome measures

Adverse Events

Patients With Nonvalvular Atrial Fibrillation (NVAF)

Serious adverse events

Other adverse events

Additional Information

Boehringer Ingelheim, Call Center

Results disclosure agreements