TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01613768

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pathological spinal fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 29 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 29 at risk
Study: NCT01613807

Adverse event: Fetal demise, placental abruption
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 20 at risk
Study: NCT01614093

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Loss of Appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Bruisng Easily
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Enuresis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Malise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hyersalavation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk
Study: NCT01614249

Adverse event: Nausea with fishy-after-taste
Serious: no
Organ System: Gastrointestinal disorders
Notes: Data collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.
Frequency: 5 affected / 107 at risk

Adverse event: Occasional vomitting in the morning after taking soft gel
Serious: no
Organ System: Gastrointestinal disorders
Notes: Data collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.
Frequency: 3 affected / 107 at risk

Adverse event: Occasional heartburn
Serious: no
Organ System: Gastrointestinal disorders
Notes: Data collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.
Frequency: 5 affected / 107 at risk

Adverse event: Occasional loose stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Data collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.
Frequency: 1 affected / 107 at risk

Adverse event: Occasional itchy skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Data collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.
Frequency: 1 affected / 107 at risk

Adverse event: Nausea with fishy-after-taste
Serious: no
Organ System: Gastrointestinal disorders
Notes: Data collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.
Frequency: 10 affected / 109 at risk

Adverse event: Occasional vomitting in the morning after taking soft gel
Serious: no
Organ System: Gastrointestinal disorders
Notes: Data collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.
Frequency: 6 affected / 109 at risk

Adverse event: Occasional heartburn
Serious: no
Organ System: Gastrointestinal disorders
Notes: Data collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.
Frequency: 3 affected / 109 at risk

Adverse event: Occasional bloated stomach
Serious: no
Organ System: Gastrointestinal disorders
Notes: Data collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.
Frequency: 2 affected / 109 at risk

Adverse event: Occasional itchy skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Data collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.
Frequency: 2 affected / 109 at risk

Adverse event: Nose Bleeding once
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: This was reported only once by one participant. Data was collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.
Frequency: 1 affected / 109 at risk
Study: NCT01614392

Adverse event: General
Serious: no
Organ System: Infections and infestations
Notes: Upper respiratory infection
Frequency: 1 affected / 25 at risk

Adverse event: General
Serious: no
Organ System: Infections and infestations
Notes: Upper respiratory infection
Frequency: 3 affected / 27 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hamstring and back pain
Frequency: 1 affected / 27 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Exacerbation of COPD
Frequency: 1 affected / 27 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Non-injurious fall
Frequency: 1 affected / 27 at risk
Study: NCT01614613

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Not study or device related, moderate severity
Frequency: 1 affected / 146 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study or device related,moderate severity
Frequency: 1 affected / 146 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not study or device related, mild
Frequency: 2 affected / 146 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not device related, moderate severity
Frequency: 1 affected / 146 at risk
Study: NCT01614769

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT01614925

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

Adverse event: Tooth hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk
Study: NCT01614990

Adverse event: Forearm Soft Tissue Necrosis
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated serious adverse event occurred in one patient who received 0.5 mg/kg macimorelin - hospitalized for a radiation-related infection following initiation of radiation treatment.
Frequency: 1 affected / 10 at risk

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

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

Adverse event: Recurrent Herpes Breakout
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk
Study: NCT01615198

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 296 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 296 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 296 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 296 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 296 at risk

Adverse event: Muscle atrophy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 296 at risk

Adverse event: Cervix carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 296 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 296 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 296 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 296 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 296 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 296 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 292 at risk

Adverse event: Henoch-Schonlein purpura nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 292 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 292 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 292 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 292 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 292 at risk
Study: NCT01615367

Adverse event: Medical Issues (Physical)
Serious: no
Organ System: Surgical and medical procedures
Notes: Breaks, sprains, infection
Frequency: 5 affected / 19 at risk

Adverse event: Unrelated Life Events
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Life events unrelated to study procedures (e.g., car accident, work injury)
Frequency: 1 affected / 19 at risk

Adverse event: Medical Issues (Physical)
Serious: no
Organ System: Surgical and medical procedures
Notes: Breaks, sprains, infection
Frequency: 2 affected / 19 at risk

Adverse event: Unrelated Life Events
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Life events unrelated to study procedures (e.g., car accident, work injury)
Frequency: 1 affected / 19 at risk

Adverse event: Worsening Psychiatric Illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk
Study: NCT01615484

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Acute Rejection
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 24 at risk

Adverse event: Cytomegalovirus (CMV)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 24 at risk

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

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

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

Adverse event: Empyema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 24 at risk
Study: NCT01615731

Adverse event: Pre-Procedure Delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 24 at risk

Adverse event: Rupture of Membranes with Subsequent Fever
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 24 at risk

Adverse event: Pre-Procedure Delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 26 at risk

Adverse event: Cervical Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 26 at risk
Study: NCT01615809

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 32 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Febrile bone marrow aplasia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Methotrexate-induced neurotoxicity
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

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

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 32 at risk

Adverse event: paleness
Serious: no
Organ System: General disorders
Frequency: 28 affected / 32 at risk

Adverse event: physical pain
Serious: no
Organ System: General disorders
Frequency: 24 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 32 at risk
Study: NCT01616056

Adverse event: Foreign body sensation
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 19 at risk

Adverse event: Swollen eye lids
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 19 at risk

Adverse event: Excessive tearing
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 19 at risk

Adverse event: Corneal edema and stromal haze
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 19 at risk
Study: NCT01616576

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

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

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk
Study: NCT01616758

Adverse event: Pathologic Hip Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Bone pain of Chest
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 22 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 22 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 22 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 22 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 22 at risk
Study: NCT01617005

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 50 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 50 at risk

Adverse event: Leukopenia with neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 50 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hepatic transaminases increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 50 at risk

Adverse event: Oral herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Polyartralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypercholesterolemia with hypertriglyceridemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 50 at risk
Study: NCT01617083

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 14 at risk
Study: NCT01617148

Adverse event: Cataract progression
Serious: yes
Organ System: Eye disorders
Notes: Patient began noticing a myopic shift, and the vision loss due to cataract progression was identified. The patient underwent uncomplicated phacoemulsification and lens implant placement with significant improvement in visual acuity.
Frequency: 1 affected / 26 at risk

Adverse event: Cataract progression
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 26 at risk
Study: NCT01617421

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

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

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

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