TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02058628

Adverse event: Brucellosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Stress
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 108 at risk

Adverse event: Vulval haematoma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 108 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 108 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 8 affected / 108 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 108 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 108 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 109 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 109 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 109 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 22 affected / 109 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 25 affected / 109 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 109 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 109 at risk
Study: NCT02058940

Adverse event: Death
Serious: yes
Organ System: Nervous system disorders
Notes: All 3 patients completed study treatment. Cause of death due to underlying neurological injury with family deciding to place patients on comfort care.
Frequency: 3 affected / 8 at risk
Study: NCT02058966

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: One subject's blood pressure reached 180/100 after ingesting Methamphetamine 20 mg pill but was in the 160s/90s for two hours before normalizing. This subject was removed from the study after this incident.
Frequency: 1 affected / 19 at risk
Study: NCT02058992

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3223 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 37 affected / 3223 at risk
Study: NCT02059005

Adverse event: Hospitalization for congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 49 at risk

Adverse event: Hospitalization for COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 49 at risk

Adverse event: Hospitalization for Diabetes
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 49 at risk

Adverse event: Hospitalization for end-stage renal disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hospitalization for pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Hospitalization for cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Suicidal ideation/attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 49 at risk

Adverse event: Hospitalization for Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hospitalization for drug/alcohol use
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: Inpatient Drug/Alcohol
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: Death, Cause Unknown
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hospitalization for congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 48 at risk

Adverse event: Hospitalization for COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 48 at risk

Adverse event: Hospitalization for Diabetes
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 48 at risk

Adverse event: Suicidal ideation/attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 48 at risk

Adverse event: Inpatient Drug/Alcohol
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 48 at risk

Adverse event: Death, Cause Unknown
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Death related to congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 48 at risk
Study: NCT02059148

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk
Study: NCT02059174

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 3 affected / 74 at risk

Adverse event: Vessel puncture site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 6 affected / 74 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Vessel puncture site reaction
Serious: no
Organ System: General disorders
Frequency: 6 affected / 74 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 74 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 55 affected / 74 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 74 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 4 affected / 76 at risk

Adverse event: Vessel puncture site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 5 affected / 76 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 76 at risk

Adverse event: Vessel puncture site reaction
Serious: no
Organ System: General disorders
Frequency: 6 affected / 76 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 76 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 50 affected / 76 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 76 at risk
Study: NCT02059642

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 146 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 146 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 146 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 146 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 146 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 152 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 152 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 152 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 152 at risk
Study: NCT02059993

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 41 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 41 at risk
Study: NCT02060058

Adverse event: Gastroenterology
Serious: no
Organ System: Gastrointestinal disorders
Notes: The most frequent AEs during therapy course were gastroenterological (12 subjects, 100%)
Frequency: 4 affected / 4 at risk

Adverse event: Dermatology
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The most frequent AEs during therapy course was dermatologic (10 subjects, 83.3%) manifestations
Frequency: 3 affected / 4 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: pregnancy
Frequency: 1 affected / 8 at risk

Adverse event: Gastroenterology
Serious: no
Organ System: Gastrointestinal disorders
Notes: The most frequent AEs during therapy course were gastroenterological (12 subjects, 100%)
Frequency: 8 affected / 8 at risk

Adverse event: Dermatology
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The most frequent AEs during therapy course was dermatologic (10 subjects, 83.3%) manifestations
Frequency: 7 affected / 8 at risk
Study: NCT02060890

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Lung infection
Frequency: 1 affected / 7 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Seizure
Frequency: 2 affected / 7 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT02060903

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 188 at risk
Study: NCT02061202

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 35 at risk

Adverse event: Candida infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 35 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 17 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 17 at risk
Study: NCT02061384

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT02061397

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Peripheral adema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk
Study: NCT02061540

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 27 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 27 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 27 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 27 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Cholangitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 27 at risk

Adverse event: Hepatomegaly
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 27 at risk
Study: NCT02061683

Adverse event: Eyelash growth
Serious: no
Organ System: Eye disorders
Frequency: 23 affected / 250 at risk

Adverse event: Pigmentation disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 250 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 190 affected / 250 at risk
Study: NCT02061696

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk

Adverse event: Discomfort and paresthesia in groin
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk
Study: NCT02062151

Adverse event: MRI with acupuncture needle in place
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk
Study: NCT02062359

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: (fever of unknown origin without clinically or microbiologically documented infection) (ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
Frequency: 1 affected / 2 at risk

Adverse event: Blood infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: Decreased platelet count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2 at risk
Study: NCT02062398

Adverse event: low grade infection and delayed closure of surgical wound
Serious: yes
Organ System: Infections and infestations
Notes: The Reprieve implant was explanted approximately after 3 weeks of treatment.Patient was treated with antibiotics. The event terminated without further sequel and was classified as non-procedural related and its relationship to the device was unknown.
Frequency: 1 affected / 13 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 13 at risk

Adverse event: Implant site discolouration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Skin irritatation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 13 at risk
Study: NCT02062437

Adverse event: Femoral fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Spiroid fracture of the thighbone due to patient fall 2 weeks after surgery.
Frequency: 1 affected / 80 at risk

Adverse event: Fracture during surgery
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Partial fracture of the Merckel, no additional procedure has been performed during the surgery.
Frequency: 1 affected / 80 at risk
Study: NCT02062463

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 197 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 197 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 197 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 197 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 197 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 197 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 197 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 197 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 197 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 197 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 197 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 197 at risk

Adverse event: Ovarian mass
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 197 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 197 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 197 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 197 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 197 at risk
Study: NCT02062580

Adverse event: HIV infection
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 71 at risk

Adverse event: Blocked nostrils
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 71 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 71 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 71 at risk

Adverse event: Rash- nonspecific
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 71 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 71 at risk

Adverse event: HIV infection
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 78 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 78 at risk

Adverse event: Blocked nostrils
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 78 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 78 at risk

Adverse event: Rash- nonspecific
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 78 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 78 at risk
Study: NCT02062593

Adverse event: Major bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 105 at risk

Adverse event: Acute confusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Wire snapped required snare retrieval
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Major bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 95 at risk

Adverse event: Crossover to PCI
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 95 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 95 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hospitalisation for atypical chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hospitalisation for right heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hospitalisation for leg pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 95 at risk

Adverse event: Severe drug reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 95 at risk