TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00775528

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 18 at risk

Adverse event: Otitis media accute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk
Study: NCT00775593

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Gastrointestinal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 53 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: E. coli sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Optic ischaemic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 53 at risk
Study: NCT00775606

Adverse event: Grade 3 elevation in ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Not related to study treatment. Related to alcohol use.
Frequency: 1 affected / 8 at risk
Study: NCT00775645

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 208 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 208 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 208 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 208 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 38 affected / 208 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 208 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 208 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 208 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 127 affected / 208 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 51 affected / 208 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 208 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 201 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 201 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 201 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 32 affected / 201 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 201 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 201 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 201 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 127 affected / 201 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 45 affected / 201 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 201 at risk
Study: NCT00775671

Adverse event: congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 23 at risk

Adverse event: Palpitations
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk
Study: NCT00776009

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 165 at risk

Adverse event: Peritonsillar abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 165 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 165 at risk
Study: NCT00776100

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk
Study: NCT00776555

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk
Study: NCT00776659

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 39 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 39 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pruritus allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 39 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 39 at risk
Study: NCT00776997

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Odynophagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: unknown causality
Frequency: 1 affected / 100 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 100 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 24 affected / 100 at risk

Adverse event: Stomach Bloating
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 100 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 100 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 100 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 8 affected / 100 at risk

Adverse event: Inability to belch or vomit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 100 at risk
Study: NCT00777023

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 186 at risk

Adverse event: Overdose; attempted suicide
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 186 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 186 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 186 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 186 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 186 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 186 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 190 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 190 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 190 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 190 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 190 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 190 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 190 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 183 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 183 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 183 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 183 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 183 at risk
Study: NCT00777062

Adverse event: Injection site reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Participant sent to dermatology clinic and they recommended monitoring the site, but no urgent action needed. Participant t finished out study visits and swelling went down.
Frequency: 1 affected / 39 at risk

Adverse event: Hospitalization for Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 39 at risk

Adverse event: Worsening of addiction symptoms
Serious: yes
Organ System: General disorders
Notes: Participant entered inpatient treatment for worsening of addiction symptoms.
Frequency: 1 affected / 39 at risk

Adverse event: Hospitalization for nausea and vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Participant said nausea was resolved on 3/7/10 and did not receive second injection. He finished his final study visit on 4/12/10.
Frequency: 1 affected / 39 at risk

Adverse event: Hospitalization for an overdose of tylenol
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 39 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 39 at risk

Adverse event: Hospitalization for Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hospitalization for pneumonia
Serious: yes
Organ System: General disorders
Notes: Participant complained of feeling ill and very fatigued. He had a high fever on 8/5/11, so study nurse recommended that he go to the ER. He was admitted on 8/5/11 with pneumonia, and released on 8/9/11.
Frequency: 1 affected / 41 at risk

Adverse event: Worsening of addiction symptoms
Serious: yes
Organ System: General disorders
Notes: Participant entered inpatient treatment for worsening of addiction symptoms.
Frequency: 1 affected / 41 at risk

Adverse event: Lacerations and fractured rib
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Participant was physically attacked and hospitalized for injuries.
Frequency: 1 affected / 41 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 41 at risk
Study: NCT00777205

Adverse event: Inpatient Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 243 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 144 at risk
Study: NCT00777257

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 444 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 444 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 450 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 451 at risk
Study: NCT00777556

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 299 at risk
Study: NCT00777608

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 53 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 53 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 53 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 53 at risk
Study: NCT00777764

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk
Study: NCT00777790

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 76 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 76 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 77 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 88 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 88 at risk
Study: NCT00777803

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 284 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 284 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 284 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 284 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 284 at risk

Adverse event: Encephalitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 97 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 97 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 97 at risk
Study: NCT00777829

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 17 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 12 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 28 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk
Study: NCT00777946

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 282 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 282 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 282 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 26 affected / 282 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 276 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 276 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 276 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 276 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 276 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 6 affected / 276 at risk

Adverse event: Traumatic pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 260 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 260 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 260 at risk
Study: NCT00778336

Adverse event: Bleeding Requiring transfusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 198 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 198 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 198 at risk

Adverse event: Haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Elevated Creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 170 at risk