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 @ 7:32 PM
Ignite Modification Date: 2025-12-25 @ 5:14 PM
NCT ID: NCT02448303
Description: None
Frequency Threshold: 5
Time Frame: Safety Analysis tracked from 0 day to 2 years.
Study: NCT02448303
Study Brief: Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1 - Pembrolizumab Monotherapy Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W). 18 None 12 33 33 33 View
Arm 2 - Acalabrutinib + Pembrolizumab Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W). 23 None 18 35 35 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Large Intestine Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Bile Duct Obstructions SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridium Difficile Colitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia Viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Failure to Thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pathological Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Metastases to Central Nervous System SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mental Status Changes SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Orthostatic Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Seasonal Allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Electrocardiogram QT Prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Amylase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Weight Increased SYSTEMATIC_ASSESSMENT Investigations None View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia 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
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tumour Pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy Peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusional State SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sleep Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper-Airway Cough Syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decubitus Ulcer SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Petechiae SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hot Flush SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Decubitus Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View