TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01995266

Adverse event: Adams-Stokes syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Asteriosclerosis Coronary Artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Sudden hearing loss
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 159 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 159 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 159 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 159 at risk

Adverse event: Monocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 159 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 159 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 159 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 159 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 159 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 159 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 159 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 159 at risk
Study: NCT01995357

Adverse event: Peristomal skin irritation/broken skin/stomal bleeding
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Definitely, probably or possibly related to the product. Causality not defined for 2 events with Test B + Training Test B
Frequency: 6 affected / 22 at risk

Adverse event: Cold or influenza
Serious: no
Organ System: Infections and infestations
Notes: Not related to the product
Frequency: 2 affected / 22 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: Not related to the product
Frequency: 1 affected / 22 at risk

Adverse event: Diarrhea or constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to the product
Frequency: 1 affected / 22 at risk

Adverse event: Peristomal skin irritation/broken skin/stomal bleeding
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Definitely, probably or possibly related to the product. Causality not defined for 2 events with Test B + Training Test B
Frequency: 9 affected / 22 at risk

Adverse event: Pain, leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to the product
Frequency: 1 affected / 22 at risk

Adverse event: Peristomal skin irritation/broken skin/stomal bleeding
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Definitely, probably or possibly related to the product. Causality not defined for 2 events with Test B + Training Test B
Frequency: 1 affected / 22 at risk

Adverse event: Cold or influenza
Serious: no
Organ System: Infections and infestations
Notes: Not related to the product
Frequency: 1 affected / 22 at risk

Adverse event: Planned operation, non-study related
Serious: no
Organ System: Eye disorders
Notes: Not related to the product
Frequency: 1 affected / 22 at risk
Study: NCT01995526

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk
Study: NCT01995539

Adverse event: Pricking sensation at insertion site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 181 at risk

Adverse event: BLEEDING AT SENSOR INSERTION SITE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: itching at sensor insertion site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 181 at risk

Adverse event: Pain at insertion site area
Serious: no
Organ System: General disorders
Frequency: 2 affected / 181 at risk

Adverse event: Skin irritation at sensor insertion site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 181 at risk
Study: NCT01995578

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 32 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 32 at risk

Adverse event: Second primary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 32 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 32 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 32 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 32 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 32 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 32 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 32 at risk
Study: NCT01995825

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 35 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 35 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 35 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk
Study: NCT01996033

Adverse event: Prostate Disease
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 25 at risk

Adverse event: Arterial Hypertension/Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: VASC Vessel Stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Arterial Hypertension/Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 25 at risk

Adverse event: Abnormal Lab Value (Suspicion of Cholangitis)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Renal artery stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk
Study: NCT01996319

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 193 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 193 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 193 at risk

Adverse event: Bone cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 193 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 193 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 193 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 193 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 193 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 193 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 193 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 193 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 193 at risk

Adverse event: Sputum increased
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 193 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 188 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 188 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 188 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 188 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 188 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 188 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 188 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 188 at risk
Study: NCT01996371

Adverse event: Compression fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Required surgical repair
Frequency: 1 affected / 5 at risk

Adverse event: Acute Chronic Back and/or Leg Pain
Serious: no
Organ System: Nervous system disorders
Notes: When appropriate treated with Valium and/or ESIs or no treatment
Frequency: 1 affected / 5 at risk

Adverse event: RTC Impingement
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: ESIs
Frequency: 1 affected / 5 at risk

Adverse event: Bilateral PEs
Serious: yes
Organ System: Vascular disorders
Notes: Subject self presented to hospital with SOB-Dyspnea leading to a diagnosis of bilateral PEs. Subject transferred and admitted to ED
Frequency: 1 affected / 4 at risk

Adverse event: Acute Chronic Back and/or Leg Pain
Serious: no
Organ System: Nervous system disorders
Notes: When appropriate treated with Valium and/or ESIs or no treatment
Frequency: 1 affected / 4 at risk

Adverse event: Allergic Reaction to dilaudid
Serious: no
Organ System: Immune system disorders
Notes: Intubated- Medical Management
Frequency: 1 affected / 4 at risk

Adverse event: ED Visit - Bronchitis/asthma attack
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Given Prednisone
Frequency: 1 affected / 4 at risk

Adverse event: Disc Herniation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient called in with increased back and leg pain after lifting a washing machine. The CNP advised imaging studies (X-rays and MRI) leading to a diagnosis of a disc herniation.
Frequency: 1 affected / 6 at risk

Adverse event: Acute Chronic Back and/or Leg Pain
Serious: no
Organ System: Nervous system disorders
Notes: When appropriate treated with Valium and/or ESIs or no treatment
Frequency: 3 affected / 6 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Narcan given
Frequency: 1 affected / 6 at risk
Study: NCT01996657

Adverse event: thrombotic envents
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: including valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.
Frequency: 5 affected / 245 at risk

Adverse event: bleeding events
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: including cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.
Frequency: 16 affected / 245 at risk

Adverse event: Deaths from other causes
Serious: yes
Organ System: Cardiac disorders
Notes: Death from Heart failure,Cancer or unexplained death
Frequency: 3 affected / 245 at risk

Adverse event: thrombotic envents
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: including valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.
Frequency: 5 affected / 245 at risk

Adverse event: bleeding events
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: including cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.
Frequency: 3 affected / 245 at risk

Adverse event: Deaths from other causes
Serious: yes
Organ System: Cardiac disorders
Notes: Death from Heart failure,Cancer or unexplained death
Frequency: 1 affected / 245 at risk

Adverse event: thrombotic envents
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: including valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.
Frequency: 14 affected / 242 at risk

Adverse event: bleeding events
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: including cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.
Frequency: 4 affected / 242 at risk

Adverse event: Deaths from other causes
Serious: yes
Organ System: Cardiac disorders
Notes: Death from Heart failure,Cancer or unexplained death
Frequency: 2 affected / 242 at risk
Study: NCT01996748

Adverse event: Ear discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 66 at risk

Adverse event: Ear discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 69 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 69 at risk
Study: NCT01996839

Adverse event: Endophthalmitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 172 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 171 at risk
Study: NCT01996943

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk
Study: NCT01997125

Adverse event: Unanticipated, device-related SAE
Serious: yes
Organ System: General disorders
Notes: Change in psychological sense of self to include functions enabled by use of the neural bridge system, resulting in the participant keeping the neuroimplant (declining explant) at the completion of the study term - deemed a UPIRSO by the study IRB.
Frequency: 1 affected / 1 at risk

Adverse event: Non-device related AE associated with spinal cord injury (anticipated)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Complications of deep tissue injury
Frequency: 1 affected / 1 at risk

Adverse event: Non-device related AE associated with spinal cord injury (anticipated)
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary tract infection and bladder stones associated with neurogenic bladder
Frequency: 1 affected / 1 at risk
Study: NCT01997281

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 13 at risk

Adverse event: increased gas-out
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: increased amount and number of defecation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk
Study: NCT01997437

Adverse event: Granulation and Fistula
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Granulation or fistula resulted in 2 patient into re-transplantation, in 1 patient in explantation and tracheostoma
Frequency: 3 affected / 6 at risk
Study: NCT01997892

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 987 at risk
Study: NCT01998243

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: peritonitis, sepsis, suture dehiscence, respiratory failure, eventration intraperitoneal postoperative bleeding
Frequency: 2 affected / 34 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Notes: mild surgical wound infection ,mild respiratory failure ,eventration, intra abdominal abscess, urinary tract infection, bleeding, haematoma,pneumonia
Frequency: 8 affected / 34 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: peritonitis, sepsis, suture dehiscence, respiratory failure, eventration intraperitoneal postoperative bleeding
Frequency: 1 affected / 32 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Notes: mild surgical wound infection ,mild respiratory failure ,eventration, intra abdominal abscess, urinary tract infection, bleeding, haematoma,pneumonia
Frequency: 7 affected / 32 at risk
Study: NCT01998360

Adverse event: Post-op bleeding or hematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Post-op infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Post-op bleeding or hematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Post-op infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 50 at risk
Study: NCT01998399

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Type II MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Complicated Para-pneumonic Effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Deep Vein Thrombosis-Right Leg
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Leukaemoid reaction
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 12 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Upper Gastrointestinal Bleed
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hematoma on forearm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk