TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00255086

Adverse event: Cardiac Arrythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Not related to study medication; incident occurred before medication was started; family notified researcher of problem and subject withdrawn.
Frequency: 1 affected / 9 at risk

Adverse event: Tattoo eyeliner
Serious: no
Organ System: Eye disorders
Notes: Study requirement is MRI. Unable to complete study procedures due to tattoo eyeliner so subject was withdrawn by the PI. Not study related.
Frequency: 1 affected / 9 at risk

Adverse event: Lethargy
Serious: no
Organ System: Psychiatric disorders
Notes: Subject discontinued medication and was terminated from the trial by the PI.
Frequency: 1 affected / 9 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Subject discontinued medication and was terminated from the trial by the PI.
Frequency: 2 affected / 9 at risk

Adverse event: Study medication non compliance
Serious: no
Organ System: Psychiatric disorders
Notes: Subject discontinued medication and was terminated from the trial by the PI.
Frequency: 3 affected / 9 at risk

Adverse event: Crohn's disease flare-ups
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related to study medication (subject was on placebo). Notified by patient. Hospitalized, treated and released, continued with study.
Frequency: 1 affected / 8 at risk

Adverse event: complications due to type II diabetes
Serious: yes
Organ System: Endocrine disorders
Notes: Not related to study medication (on placebo). Hospitalized, withdrawn from study. Later died.
Frequency: 1 affected / 8 at risk
Study: NCT00255125

Adverse event: Mild gastrointestinal symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: GI symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 42 at risk

Adverse event: Mild gastrointestinal symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 44 at risk

Adverse event: GI symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 44 at risk
Study: NCT00255151

Adverse event: Diarrhoea (Excluding [Excl] Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 140 at risk

Adverse event: Gastritis (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 140 at risk

Adverse event: Gastrointestinal and Abdominal Pains (Excl Oral and Throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 140 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 140 at risk

Adverse event: Pain and Discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Uterine Disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 159 at risk

Adverse event: Diarrhoea (Excluding [Excl] Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 159 at risk

Adverse event: Flatulence, Bloating and Distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 159 at risk

Adverse event: Gastritis (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 159 at risk

Adverse event: Gastrointestinal and Abdominal Pains (Excl Oral and Throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 159 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 159 at risk

Adverse event: Coronary Artery Disorders Not Elsewhere Classified (NEC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 152 at risk

Adverse event: Acute and Chronic Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Non-site Specific Injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 152 at risk

Adverse event: Musculoskeletal and Connective Tissue Signs and Symptoms NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 152 at risk

Adverse event: Breast and Nipple Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 152 at risk

Adverse event: Diarrhoea (Excluding [Excl] Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 152 at risk

Adverse event: Flatulence, Bloating and Distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 152 at risk

Adverse event: Gastritis (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 152 at risk

Adverse event: Gastrointestinal and Abdominal Pains (Excl Oral and Throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 152 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 152 at risk
Study: NCT00255164

Adverse event: Diarrhoea (Excluding [Excl] Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 140 at risk

Adverse event: Gastritis (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 140 at risk

Adverse event: Gastrointestinal and Abdominal Pains (Excl Oral and Throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 140 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 140 at risk

Adverse event: Pain and Discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Uterine Disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 159 at risk

Adverse event: Diarrhoea (Excluding [Excl] Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 159 at risk

Adverse event: Flatulence, Bloating and Distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 159 at risk

Adverse event: Gastritis (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 159 at risk

Adverse event: Gastrointestinal and Abdominal Pains (Excl Oral and Throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 159 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 159 at risk

Adverse event: Coronary Artery Disorders Not Elsewhere Classified (NEC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 152 at risk

Adverse event: Acute and Chronic Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Non-site Specific Injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 152 at risk

Adverse event: Musculoskeletal and Connective Tissue Signs and Symptoms NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 152 at risk

Adverse event: Breast and Nipple Neoplasms Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 152 at risk

Adverse event: Diarrhoea (Excluding [Excl] Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 152 at risk

Adverse event: Flatulence, Bloating and Distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 152 at risk

Adverse event: Gastritis (Excl Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 152 at risk

Adverse event: Gastrointestinal and Abdominal Pains (Excl Oral and Throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 152 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 152 at risk
Study: NCT00255346

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hemorrhage CNS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 68 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 68 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 68 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 68 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 12 affected / 68 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 68 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 68 at risk

Adverse event: Platelets/Hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 68 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 68 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 68 at risk
Study: NCT00255684

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 16 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Post-transplant lymphoproliferative disorder
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Inappropriate antidiuretic hormone secretion
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 16 at risk

Adverse event: relapsed transplant resulting in death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 16 at risk
Study: NCT00256217

Adverse event: Sores in mouth and between fingers
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk
Study: NCT00256282

Adverse event: Febrile neutropenia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 52 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 42 affected / 52 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 52 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 52 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 52 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 40 affected / 52 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 13 affected / 52 at risk
Study: NCT00256295

Adverse event: Death due to disease progression
Serious: yes
Organ System: General disorders
Notes: These events were not study related.
Frequency: 4 affected / 7 at risk

Adverse event: Dehydration due to disease progression
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: This event was not study related.
Frequency: 1 affected / 7 at risk

Adverse event: Pneumonia due to disease progression
Serious: yes
Organ System: Infections and infestations
Notes: This event was not study related.
Frequency: 1 affected / 7 at risk

Adverse event: Carotid artery rupture due to disease progression
Serious: yes
Organ System: Vascular disorders
Notes: This event was not study related.
Frequency: 1 affected / 7 at risk

Adverse event: Grade II Hepatic toxicity
Serious: yes
Organ System: Hepatobiliary disorders
Notes: This event was not study related.
Frequency: 1 affected / 7 at risk

Adverse event: Broken leg due to fall
Serious: yes
Organ System: General disorders
Notes: This event required hospitalization and was not study related.
Frequency: 1 affected / 7 at risk

Adverse event: Grade 3 Sinus Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: This event was not study related.
Frequency: 1 affected / 7 at risk
Study: NCT00256776

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 135 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 135 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 135 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 135 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 135 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 135 at risk

Adverse event: Asthenia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 135 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 135 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 135 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 135 at risk

Adverse event: Various other SAEs
Serious: yes
Organ System: General disorders
Frequency: 31 affected / 135 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 134 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 134 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 134 at risk

Adverse event: Vascular pain
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 134 at risk

Adverse event: Asthenia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 134 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 134 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 134 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 134 at risk

Adverse event: Various other SAEs
Serious: yes
Organ System: General disorders
Frequency: 30 affected / 134 at risk
Study: NCT00256984

Adverse event: Full blood count abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 75 at risk

Adverse event: Colostomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 75 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 75 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Gastrointestinal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk

Adverse event: Haematoma infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Gastrointestinal hypomotility
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Postprocedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 75 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Rectal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Suture related complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 75 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 75 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 75 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 75 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 75 at risk
Study: NCT00257309

Adverse event: Major bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Major haemorrhage
Frequency: 5 affected / 134 at risk

Adverse event: Mechanical complications
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac rupture (free wall rupture, interventiruclar septal rupture, papillary muscle rupture)
Frequency: 4 affected / 134 at risk

Adverse event: Red blood transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 134 at risk

Adverse event: Major hemorrhage or transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 134 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 134 at risk

Adverse event: Major bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Major haemorrhage
Frequency: 6 affected / 132 at risk

Adverse event: Mechanical complications
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac rupture (free wall rupture, interventiruclar septal rupture, papillary muscle rupture)
Frequency: 4 affected / 132 at risk

Adverse event: Red blood transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 132 at risk

Adverse event: Major hemorrhage or transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 132 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 132 at risk
Study: NCT00257660

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 55 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 55 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 55 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 61 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 61 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 61 at risk
Study: NCT00257725

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 11 at risk

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

Adverse event: Affect lability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 11 at risk

Adverse event: Trouble Sleeping
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 11 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Increased Sensitivity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Virus with fever and headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk
Study: NCT00257894

Adverse event: Hospitalisation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Broke wrist when in a domestic altercation.
Frequency: 1 affected / 20 at risk
Study: NCT00258310

Adverse event: Respiratory failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hand Foot Syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 35 at risk