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 @ 11:47 PM
Ignite Modification Date: 2025-12-25 @ 9:40 PM
NCT ID: NCT02764151
Description: The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Frequency Threshold: 5
Time Frame: Baseline up to 1 year
Study: NCT02764151
Study Brief: First in Patient Study for PF-06840003 in Malignant Gliomas
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-06840003 125 MG QD PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles. 0 None 0 2 2 2 View
PF-06840003 250 MG QD PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles. 0 None 1 4 4 4 View
PF-06840003 250 MG BID PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles. 0 None 0 3 3 3 View
PF-06840003 500 MG BID PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles. 0 None 3 8 8 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Glioblastoma multiforme NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Generalised tonic-clonic seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Hemiparesis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Left ventricular dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.1 View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.1 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.1 View
Anal incontinence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Fungal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Ejection fraction decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Protein total increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Temporomandibular joint syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Glioblastoma multiforme NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Haemangioma of skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Amnesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Brain oedema NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Disturbance in attention NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Dysarthria NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Facial paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Facial paresis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Hemianopia homonymous NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Hemiparesis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Nystagmus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Partial seizures NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Peroneal nerve palsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Pyramidal tract syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Visual field defect NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Dysphoria NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Personality change NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Chromaturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Polyuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Sneezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Aphasia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Apraxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Ataxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Micturition urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View