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 @ 7:07 PM
Ignite Modification Date: 2025-12-25 @ 4:40 PM
NCT ID: NCT02586857
Description: None
Frequency Threshold: 5
Time Frame: Reported Adverse Events (AEs) include starting on or after Day 0 and on or before Day 940.
Study: NCT02586857
Study Brief: A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 Acalabrutinib 200mg administered orally (PO) twice daily (BID). 12 None 6 15 15 15 View
Cohort 2 - Acalabrutinib Acalabrutinib 400mg PO (QD) 7 None 4 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haemorrhage Intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Large Intestine Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Influenze SYSTEMATIC_ASSESSMENT Infections and infestations None View
Streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Brain Oedema SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Rash Macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haemorrhoidal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Catheter Site Pain SYSTEMATIC_ASSESSMENT General disorders None View
Gait Disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders None View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Chest Discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Feeling Cold SYSTEMATIC_ASSESSMENT General disorders None View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oesophageal Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tinea Pedis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
CD4 Lymphocytes Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Vitamin D Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations None View
White Blood Cell Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Increased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depressed Level of Consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Brain Oedema SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cognitive Disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Disturbance in Attention SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cognitive Disoder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Disturbance in Attention SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Micturition Urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Apiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash Macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sinus Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Cerumen Impaction SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vertigo Positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Parosmia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinitis Allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis Aceneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hot Flush SYSTEMATIC_ASSESSMENT Vascular disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View