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 @ 2:19 PM
Ignite Modification Date: 2025-12-25 @ 12:56 PM
NCT ID: NCT02529995
Description: Systematic assessment due to regular investigator assessment at study visits.
Frequency Threshold: 5
Time Frame: AEs from start of study drug until 28 days post treatment discontinuation or 12 months after LSFD. Results are based on data cut off of 2 Nov 2016.
Study: NCT02529995
Study Brief: Phase I, Study in Chinese NSCLC Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD9291 40mg Single oral dose of AZD9291 40mg on Cycle 0 Day 1 None None 3 15 15 15 View
AZD9291 80mg Single oral dose of AZD9291 80mg on Cycle 0 Day 1 None None 5 16 16 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Cerebral artery embolism SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Eye swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Xerophthalmia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Anal inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Lip dry SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Oral mucosal exfoliation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Dermatophytosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood bilirubin unconjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood creatinine abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Electrocardiogram QT interval abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Red blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypochloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypoproteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Femoral hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Dysstasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Nervous system disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Post herpetic neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Soliloquy SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Hydrothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Nail discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Onychomadesis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Pigmentation disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Skin fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View