TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00473083

Adverse event: Pancreatitis
Serious: yes
Organ System: Endocrine disorders
Notes: From treatment arm 1, however this SAE did not lead to discontinuation of treatment.
Frequency: 1 affected / 49 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

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

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 5 affected / 49 at risk

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

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

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

Adverse event: Pancreatitis
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 49 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 49 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Chromaturia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Blister
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Rash
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Dry skin
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 50 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Parsomia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain of skin
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk
Study: NCT00473434

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Lethargy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Encephalitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 64 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 64 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 64 at risk

Adverse event: Dystonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Extrapyramidal disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 64 at risk

Adverse event: Hallucination, auditory
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 64 at risk

Adverse event: Mental disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 64 at risk

Adverse event: Paranoia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 64 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 64 at risk

Adverse event: Schizoaffective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 64 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 64 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 64 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 64 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 64 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 64 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 64 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 64 at risk

Adverse event: Akathisia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 64 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 64 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 64 at risk
Study: NCT00473564

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 170 at risk

Adverse event: oral cavity hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 170 at risk

Adverse event: diffuse pharyngeal swelling
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: excessive mucus in throat
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: ARDS with respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: pneumonia with respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Localised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 170 at risk

Adverse event: Chylothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

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

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 170 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 170 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 170 at risk

Adverse event: oral yeast infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 170 at risk

Adverse event: Trismus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 170 at risk

Adverse event: Laryngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 170 at risk
Study: NCT00473642

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: greater than 2 months after last ranibizumab
Frequency: 1 affected / 10 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Notes: following hip fracture and complications greater than 2 months after ranibizumab
Frequency: 1 affected / 10 at risk
Study: NCT00473655

Adverse event: Femur And Rotula Right Fracture That Required Hospitalization
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 111 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 111 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 111 at risk

Adverse event: Cephalea
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 111 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 111 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 112 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 112 at risk

Adverse event: Cephalea
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 112 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 112 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 112 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 111 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 111 at risk

Adverse event: Cephalea
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 111 at risk
Study: NCT00473668

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 87 affected / 97 at risk

Adverse event: Redness (mm)
Serious: no
Organ System: General disorders
Frequency: 73 affected / 97 at risk

Adverse event: Swelling (mm)
Serious: no
Organ System: General disorders
Frequency: 80 affected / 97 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 64 affected / 96 at risk

Adverse event: Fever (Axillary)
Serious: no
Organ System: General disorders
Frequency: 77 affected / 96 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 75 affected / 96 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 55 affected / 96 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 84 affected / 96 at risk

Adverse event: Redness (mm)
Serious: no
Organ System: General disorders
Frequency: 74 affected / 96 at risk

Adverse event: Swelling (mm)
Serious: no
Organ System: General disorders
Frequency: 76 affected / 96 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 58 affected / 96 at risk

Adverse event: Fever (Axillary)
Serious: no
Organ System: General disorders
Frequency: 73 affected / 96 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 69 affected / 96 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 45 affected / 96 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 81 affected / 95 at risk

Adverse event: Redness (mm)
Serious: no
Organ System: General disorders
Frequency: 68 affected / 95 at risk

Adverse event: Swelling (mm)
Serious: no
Organ System: General disorders
Frequency: 68 affected / 95 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 46 affected / 95 at risk

Adverse event: Fever (Axillary)
Serious: no
Organ System: General disorders
Frequency: 57 affected / 95 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 61 affected / 95 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 40 affected / 95 at risk
Study: NCT00473876

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Notes: 2 patients in the metformin arm had acute coronary syndrome prior to starting on metformin. Therefore, reported as serious adverse event. Causality to metformin: Not related.
Frequency: 2 affected / 39 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild to moderate in severity
Frequency: 18 affected / 39 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Renal and urinary disorders
Notes: 1 patient in the placebo arm was diagnosed prostate cancer prior to starting on placebo. Therefore reported as serious adverse event. Causality to event: Not related.
Frequency: 1 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild to moderate in severity
Frequency: 3 affected / 23 at risk
Study: NCT00474175

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Post operation wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 233 at risk

Adverse event: Tooth caries Not Otherwise Specified (NOS)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 233 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 233 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 233 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 233 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 228 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 228 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 228 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 228 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 228 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 228 at risk
Study: NCT00474851

Adverse event: Hospitalization for pelvic/abdominal pain
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: All events determined to be likely due to flare of subject's underlying disease, endometriosis
Frequency: 3 affected / 25 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Bone fractures, secondary to fall or trauma. Non spontaneous, not low impact
Frequency: 3 affected / 25 at risk

Adverse event: Myalgias/arthralgias
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Pain that did not require hospitalization or surgery
Frequency: 8 affected / 25 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 25 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 25 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 26 at risk

Adverse event: Myalgias/arthralgias
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Pain that did not require hospitalization or surgery
Frequency: 8 affected / 26 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 26 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk
Study: NCT00474955

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Right acromioclavicular joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Erythema nodosum
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Weber-Christian disease
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk
Study: NCT00474994

Adverse event: Death not associated with CTCAE term- Death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Death not associated with CTCAE term-Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 53 at risk

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

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Gastrointestinal 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: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Ulcer, Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 53 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 53 at risk

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

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 53 at risk

Adverse event: Gastrointestinal, other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 53 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 53 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 53 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 53 at risk

Adverse event: Mucositis (Clincal exam)- Oral cavity
Serious: no
Organ System: General disorders
Frequency: 7 affected / 53 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 53 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 53 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 53 at risk
Study: NCT00475176

Adverse event: Rash attributed to ribavirin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

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