TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00633880

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 50 at risk

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

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Mental status change
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 51 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 51 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 181 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 181 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 181 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 181 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 181 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 181 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 181 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 181 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 181 at risk
Study: NCT00633919

Adverse event: Femur fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unlikely related to specific immunotherapy, severe
Frequency: 1 affected / 63 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unlikely related to specific immunotherapy, severe
Frequency: 1 affected / 63 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 63 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 63 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 63 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 63 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 63 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Notes: Unlikely related to specific immunotherapy, moderate in severity
Frequency: 1 affected / 61 at risk

Adverse event: Obsessive-compulsive disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: Unlikely related to specific immunotherapy, severe
Frequency: 1 affected / 61 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 61 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 61 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk
Study: NCT00633932

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 190 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 190 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 189 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 189 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 189 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 190 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 190 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 190 at risk
Study: NCT00633984

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 7 affected / 87 at risk

Adverse event: Neurological
Serious: no
Organ System: General disorders
Frequency: 6 affected / 87 at risk

Adverse event: GI
Serious: no
Organ System: General disorders
Frequency: 5 affected / 87 at risk

Adverse event: Cognitive/Emotional
Serious: no
Organ System: General disorders
Frequency: 3 affected / 87 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 87 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 4 affected / 82 at risk

Adverse event: Neurological
Serious: no
Organ System: General disorders
Frequency: 4 affected / 82 at risk

Adverse event: GI
Serious: no
Organ System: General disorders
Frequency: 4 affected / 82 at risk

Adverse event: Cognitive/Emotional
Serious: no
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Genitourinary
Serious: no
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 5 affected / 82 at risk
Study: NCT00634036

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

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

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

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 12 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

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

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 11 at risk

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

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 11 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 11 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 4 affected / 11 at risk
Study: NCT00634322

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 5 at risk
Study: NCT00634543

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 76 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 76 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 76 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 76 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 80 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 80 at risk
Study: NCT00634569

Adverse event: Cellulitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Bronchiectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 10 affected / 24 at risk

Adverse event: Diastolic hypotension
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 24 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 24 at risk

Adverse event: Hypotension
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 24 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 24 at risk
Study: NCT00634907

Adverse event: Venous thromboembolic event or bleed
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 114 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Notes: Minor bleeds did not require hospitalization
Frequency: 1 affected / 114 at risk

Adverse event: Venous thromboembolic event or bleed
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 115 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Notes: Minor bleeds did not require hospitalization
Frequency: 6 affected / 115 at risk
Study: NCT00635024

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

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

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

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk
Study: NCT00635050

Adverse event: Hospitalisation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Transferred to hospital from an outside institution because of suspected Stevens-Johnson syndrome. Found to have grade 3 hand-foot syndrome. Sent home on 3rd day after symptomatic treatment, then she resumed and completed her preoperative treatment.
Frequency: 1 affected / 32 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: any grade
Frequency: 17 affected / 32 at risk

Adverse event: hand-foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: palmar-plantar erythrodysesthesia, any grade. 1 participant had grade 3 event
Frequency: 23 affected / 32 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 3
Frequency: 1 affected / 32 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 3
Frequency: 1 affected / 32 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Notes: grade 3
Frequency: 7 affected / 32 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 3
Frequency: 6 affected / 32 at risk
Study: NCT00635128

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 257 affected / 351 at risk

Adverse event: Redness (mm)
Serious: no
Organ System: General disorders
Frequency: 169 affected / 351 at risk

Adverse event: Swelling (mm)
Serious: no
Organ System: General disorders
Frequency: 141 affected / 351 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was collected only from subjects with their symptom sheets completed.
Frequency: 87 affected / 351 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was collected only from subjects with their symptom sheets completed.
Frequency: 41 affected / 351 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was collected only from subjects with their symptom sheets completed.
Frequency: 76 affected / 351 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 45 affected / 64 at risk

Adverse event: Redness (mm)
Serious: no
Organ System: General disorders
Frequency: 26 affected / 64 at risk

Adverse event: Swelling (mm)
Serious: no
Organ System: General disorders
Frequency: 22 affected / 64 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was collected only from subjects with their symptom sheets completed.
Frequency: 14 affected / 63 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was collected only from subjects with their symptom sheets completed.
Frequency: 4 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was collected only from subjects with their symptom sheets completed.
Frequency: 12 affected / 63 at risk
Study: NCT00635349

Adverse event: Thromboangiitis obliterans
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 73 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 73 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 73 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 73 at risk

Adverse event: Dizziness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 73 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 67 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 67 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 67 at risk

Adverse event: Dizziness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 67 at risk
Study: NCT00635362

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 22 at risk

Adverse event: Chlamydia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk
Study: NCT00635479

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 49 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Device failure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 49 at risk

Adverse event: prescription overdose
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

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

Adverse event: Pneumomediastinum
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 42 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Device failure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 42 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 42 at risk

Adverse event: Regional Pain Syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 42 at risk

Adverse event: malignancy, unrelated
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 42 at risk

Adverse event: fall, no injury
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk
Study: NCT00635570

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 73 affected / 136 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 83 affected / 136 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 136 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 93 affected / 136 at risk

Adverse event: Breast swelling
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 71 affected / 136 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 136 at risk

Adverse event: Vulvovaginal discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 75 affected / 136 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 46 affected / 136 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 78 affected / 137 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 137 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 137 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 102 affected / 137 at risk

Adverse event: Breast swelling
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 82 affected / 137 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 137 at risk

Adverse event: Vulvovaginal discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 58 affected / 137 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 15 affected / 137 at risk
Study: NCT00635609

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Intensity severe, unlikely related
Frequency: 1 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 48 at risk

Adverse event: Sunburn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 48 at risk

Adverse event: Ruptured ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Intensity severe, unlikely related
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 45 at risk

Adverse event: Sunburn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 45 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 45 at risk