TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01282203

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1122 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1122 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1122 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1122 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1122 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1122 at risk

Adverse event: Post-procedural hemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1122 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1122 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1122 at risk
Study: NCT01282814

Adverse event: Tachycardia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 7 affected / 24 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: High Blood Pressure
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Bradycardia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 6 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk
Study: NCT01282866

Adverse event: injured ankle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 35 at risk
Study: NCT01283022

Adverse event: Cryptorchism *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 24 at risk

Adverse event: Hydrocele *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 24 at risk

Adverse event: Abnormal labour affecting foetus +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 1 affected / 24 at risk

Adverse event: Foetal heart rate disorder +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 2 affected / 24 at risk

Adverse event: Infantile apnoeic attack *
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 24 at risk

Adverse event: Neonatal respiratory distress syndrome *
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 24 at risk

Adverse event: Abnormal labour affecting foetus +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 2 affected / 24 at risk

Adverse event: Arrested labour +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 5 affected / 24 at risk

Adverse event: Foetal heart rate disorder +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 5 affected / 24 at risk

Adverse event: Meconium in amniotic fluid +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 5 affected / 24 at risk

Adverse event: Umbilical cord around neck *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 4 affected / 24 at risk

Adverse event: Uterine contractions abnormal +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 2 affected / 24 at risk

Adverse event: Hypotension +
Serious: no
Organ System: Vascular disorders
Notes: + Intrapartum Event
Frequency: 3 affected / 24 at risk

Adverse event: Apgar score low *
Serious: no
Organ System: Investigations
Notes: \* Neonatal Event
Frequency: 2 affected / 24 at risk

Adverse event: Caput succedaneum *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 2 affected / 24 at risk

Adverse event: Cephalohaematoma *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 2 affected / 24 at risk

Adverse event: Infection prophylaxis *
Serious: no
Organ System: Surgical and medical procedures
Notes: \* Neonatal Event
Frequency: 3 affected / 24 at risk
Study: NCT01283035

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 5 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Chelitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Oral mucositis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Throat tightening
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk
Study: NCT01283152

Adverse event: Death
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hemoperitoneum--Not related
Frequency: 1 affected / 25 at risk

Adverse event: Recurrent HE
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Possibly study related
Frequency: 2 affected / 25 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiorespiratory---not related
Frequency: 2 affected / 25 at risk

Adverse event: Recurrent HE
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Possibly study related
Frequency: 1 affected / 25 at risk

Adverse event: Endotracheal intubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Probably not related
Frequency: 1 affected / 25 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Probably not related
Frequency: 1 affected / 25 at risk
Study: NCT01283321

Adverse event: Excessive mediastinal bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 10 at risk

Adverse event: Excessive mediastinal bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 10 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 10 at risk
Study: NCT01283334

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient admitted to emergency department (ED)
Frequency: 1 affected / 20 at risk

Adverse event: Hemoptysis and death
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 20 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 20 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 20 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pneumonia aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 20 at risk
Study: NCT01283464

Adverse event: inpatient admission for pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: inpatient admission for orthopedic surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 12 at risk

Adverse event: inpatient admission for near syncopal episode
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT01283542

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 20 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 20 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk
Study: NCT01283555

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 25 at risk

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

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk
Study: NCT01284127

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Notes: Self reported fatigue
Frequency: 10 affected / 38 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Self reported joint pain
Frequency: 2 affected / 38 at risk

Adverse event: Mouth sores
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Self reported mouth sores
Frequency: 2 affected / 38 at risk
Study: NCT01284361

Adverse event: Haemorrhage
Serious: no
Organ System: Renal and urinary disorders
Notes: reported mild urethral bleeding after using one 30 cm catheter
Frequency: 1 affected / 91 at risk

Adverse event: Discomfort
Serious: no
Organ System: Renal and urinary disorders
Notes: reported mild pain when he used all ten 30 cm catheters
Frequency: 1 affected / 91 at risk
Study: NCT01284426

Adverse event: Remission of chronic urticaria after 1 year of symptoms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Remission of chronic urticaria (CU) after 1 year of the onset of symptoms was considered if symptoms did not recur for at least 12 months without medication after 1 years of CU symptoms.
Frequency: 17 affected / 92 at risk

Adverse event: Remission of chronic urticaria after 3 years of symptoms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Remission of chronic urticaria (CU) after 3 years of the onset of symptoms was considered if symptoms did not recur for at least 12 months without medication after 3 years of CU symptoms.
Frequency: 50 affected / 92 at risk

Adverse event: Remission of chronic urticaria (CU) after 5 years of symptoms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Remission of chronic urticaria (CU) after 5 years of the onset of symptoms was considered if symptoms did not recur for at least 12 months without medication after 5 years of CU symptoms.
Frequency: 62 affected / 92 at risk
Study: NCT01284517

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 177 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 177 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 177 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 177 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 177 at risk

Adverse event: Depression suicidal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 177 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 177 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 177 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 177 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 177 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 177 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 177 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 177 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 177 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 177 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 171 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 171 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 171 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 171 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 171 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 171 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 171 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 171 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 171 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 171 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 171 at risk
Study: NCT01284621

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk
Study: NCT01284959

Adverse event: Abdominal discomfort(vomiting)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Sedation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Sedation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 11 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Sedation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT01285024

Adverse event: PE/DVT
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 49 at risk

Adverse event: Urinary Retention/Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: PE/DVT
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Wound drainiage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 60 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 60 at risk

Adverse event: Edema with pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 60 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk
Study: NCT01285050

Adverse event: Haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: As an expected potential complication of liver biopsy, one patient had bleeding that required observation in the hospital. No residual complications were noted.
Frequency: 1 affected / 20 at risk
Study: NCT01285102

Adverse event: Elevated ALP
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: Biliary obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk
Study: NCT01285843

Adverse event: Revision
Serious: yes
Organ System: Surgical and medical procedures
Notes: Femoral neck fracture following an accident. The patient has been operated and revised
Frequency: 1 affected / 20 at risk
Study: NCT01285908

Adverse event: Eccymoses
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Ecchymoses in the arms after failed attempts to place brachial and radial arterial catheters
Frequency: 1 affected / 6 at risk
Study: NCT01286168

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Notes: Surgical site infection per operated side within one year of operation. Includes only infections that occurred before a secondary operation such as tissue expander/implant exchange.
Frequency: 3 affected / 104 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Notes: Surgical site infection per operated side within one year of operation. Includes only infections that occurred before a secondary operation such as tissue expander/implant exchange.
Frequency: 6 affected / 104 at risk