Adverse Events Module

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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: 2025-12-24 @ 10:45 PM
Ignite Modification Date: 2025-12-25 @ 8:15 PM
NCT ID: NCT02299635
Description: None
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT02299635
Study Brief: A Study Evaluating PF-03084014 In Patients With Advanced Breast Cancer With Or Without Notch Alterations
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-03084014 PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first. None None 6 19 18 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disease progression NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Transitional cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Eye discharge NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Photopsia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Vitreous floaters NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood chloride decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Carbon dioxide increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Electrocardiogram QT prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Glomerular filtration rate decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Protein total increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypouricaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Tumour exudation NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Tumour haemorrhage NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Tumour pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Balance disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Upper respiratory tract inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Nail dystrophy NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Palmar-plantar erythrodysaesthesia syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash macular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View