Adverse Events Module

Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module


Ignite Creation Date: 2025-12-25 @ 3:08 AM
Ignite Modification Date: 2025-12-26 @ 1:47 AM
NCT ID: NCT02129205
Description: None
Frequency Threshold: 5
Time Frame: 3 years
Study: NCT02129205
Study Brief: A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PF-06650808 0.2 mg/kg PF-06650808 0.2 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. 0 None 0 2 2 2 View
PF-06650808 0.4 mg/kg PF-06650808 0.4 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. 0 None 0 2 2 2 View
PF-06650808 0.8 mg/kg PF-06650808 0.8 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. 0 None 0 2 2 2 View
PF-06650808 1.6 mg/kg PF-06650808 1.6 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. 0 None 0 2 2 2 View
PF-06650808 2.0 mg/kg PF-06650808 2.0 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. 1 None 1 7 7 7 View
PF-06650808 2.4 mg/kg PF-06650808 2.4 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. 1 None 3 11 11 11 View
PF-06650808 3.0 mg/kg PF-06650808 3.0 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. 0 None 3 6 6 6 View
PF-06650808 3.6 mg/kg PF-06650808 3.6 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. 0 None 3 6 6 6 View
PF-06650808 4.68 mg/kg PF-06650808 4.68 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. 0 None 2 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Enterocolitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Disease progression NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Multiple organ dysfunction syndrome NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Tumour pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Rash macular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Left ventricular dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 20.0 View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Foreign body sensation in eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Cheilitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Eructation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Haematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Rectal tenesmus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Retching NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Adverse drug reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Induration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 20.0 View
Candida infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Activated partial thromboplastin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood alkaline phosphatase NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood creatine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood parathyroid hormone increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Electrocardiogram QT prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
International normalised ratio increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
White blood cell count NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
White blood cell count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hyperuricaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Muscle tightness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Musculoskeletal discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Tumour pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Cognitive disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Nystagmus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Restless legs syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Breast pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.0 View
Menopausal symptoms NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.0 View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Sinus pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Upper respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Upper-airway cough syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Dermal cyst NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Skin hyperpigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Systolic hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View