TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02115386

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 7 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Bilirubin conjugated increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 7 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 7 at risk

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

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

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT02115828

Adverse event: chest pain and shortness of breath
Serious: yes
Organ System: Cardiac disorders
Notes: This is a 65 yr old man with Prostate CA , admitted for chest pain and shortness of breath. A cardiac event was ruled out. The cause of his symptoms appeared to be related to his metastatic prostate cancer process.
Frequency: 1 affected / 9 at risk

Adverse event: observation post-TACE
Serious: yes
Organ System: Hepatobiliary disorders
Notes: 60 year old man with prostate cancer underwent TACE to his liver metastases and and was admitted to the hospital for one night for observation post-TACE. This hospitalization was NOT RELATED to the study drug, vismodegib
Frequency: 1 affected / 9 at risk

Adverse event: Pain grade 3
Serious: yes
Organ System: General disorders
Notes: patient was admitted om 07/15/2015 for pain control issues, SAE was not related to the study drug
Frequency: 1 affected / 9 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: patient was admitted for grade 3 pneumonia. the SAE was not related to the study drug
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient was admitted for grade 3 nausea, the SAE was possibly related to the study drug
Frequency: 1 affected / 9 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient was admitted for grade 3 vomiting, this SAE was possibly related to the study drug.
Frequency: 1 affected / 9 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Patient was admitted for grade 3 dehydration, the SAE was possibly related to the study drug
Frequency: 1 affected / 9 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 9 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 9 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 9 at risk
Study: NCT02115984

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 33 at risk

Adverse event: Dry eye
Serious: yes
Organ System: Eye disorders
Frequency: 13 affected / 33 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 33 at risk

Adverse event: Alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 57 affected / 57 at risk

Adverse event: Nausea after the CT (before day 7)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 57 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hive-like allergic reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Herpetic eruption
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 11 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 11 at risk

Adverse event: Dry eye
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 23 at risk

Adverse event: Nausea after the CT (before day 7)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 23 at risk
Study: NCT02116309

Adverse event: Arrythmia after ERCP
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 482 at risk

Adverse event: Hypertension after ERCP
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 482 at risk

Adverse event: Post sphincterotomy bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 477 at risk

Adverse event: Hypertension after ERCP
Serious: no
Organ System: Cardiac disorders
Frequency: 35 affected / 477 at risk
Study: NCT02116608

Adverse event: Death
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Viral Respiratory Infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Viral Respiratory Infection
Frequency: 1 affected / 9 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vascular device infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk
Study: NCT02116660

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Gonorrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Lichen planus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 5 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk
Study: NCT02116972

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 102 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 102 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 102 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 104 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 104 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 104 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 104 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 104 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 100 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 100 at risk
Study: NCT02117193

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 10 at risk
Study: NCT02117349

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Gastrointestinal norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Incision site cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Stoma site cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Post procedural bile leak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 36 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 36 at risk

Adverse event: Gastrointestinal stoma output abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Incision site cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Stoma site cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Post procedural bile leak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

Adverse event: Gastrointestinal stoma output abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk
Study: NCT02117687

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk
Study: NCT02117999

Adverse event: Corneal sub-epithelial infiltrates
Serious: no
Organ System: Eye disorders
Notes: Corneal peripheral sub-epithelial infiltrates
Frequency: 1 affected / 10 at risk
Study: NCT02118012

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 6 affected / 12 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Nervousness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 12 at risk

Adverse event: Inability to concentrate
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Numbness or Tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Difficulty Urinating
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 5 affected / 12 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: Nervousness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Inability to concentrate
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 12 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Numbness or Tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 12 at risk

Adverse event: Difficulty Urinating
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk
Study: NCT02118441

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 62 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 63 at risk
Study: NCT02118610

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 9 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 29 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

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

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

Adverse event: Salivary hypersecretion
Serious: no
Organ System: General disorders
Frequency: 5 affected / 29 at risk

Adverse event: Tinnitus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

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

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

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 10 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 32 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 5 affected / 32 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 32 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: General disorders
Frequency: 9 affected / 32 at risk

Adverse event: Tinnitus
Serious: no
Organ System: General disorders
Frequency: 7 affected / 32 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 9 affected / 32 at risk
Study: NCT02118961

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 167 affected / 223 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 95 affected / 223 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 125 affected / 223 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 132 affected / 223 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 162 affected / 223 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 115 affected / 223 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 223 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 223 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 223 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 160 affected / 222 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 84 affected / 222 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 85 affected / 222 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 113 affected / 222 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 148 affected / 222 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 87 affected / 222 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 222 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 222 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 222 at risk
Study: NCT02119299

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Subject discontinued due to becoming pregnant during study.
Frequency: 1 affected / 76 at risk
Study: NCT02119325

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 96 at risk
Study: NCT02119442

Adverse event: infective endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 90 at risk
Study: NCT02119871

Adverse event: Neurological deficit
Serious: no
Organ System: Nervous system disorders
Notes: Any type of postoperative transient or permanent neurological dysfunction detected at routine bedside investigation.
Frequency: 1 affected / 10 at risk

Adverse event: Neurological deficit
Serious: no
Organ System: Nervous system disorders
Notes: Any type of postoperative transient or permanent neurological dysfunction detected at routine bedside investigation.
Frequency: 1 affected / 10 at risk