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: 2025-12-25 @ 2:49 AM
Ignite Modification Date: 2025-12-26 @ 1:31 AM
NCT ID: NCT02163733
Description: Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 15), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).
Frequency Threshold: 5
Time Frame: Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 months for Overall (Parts A and B combined).
Study: NCT02163733
Study Brief: Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With 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
Overall Safety Population Parts A and B of the study combined. 2 None 8 38 38 38 View
Part A Safety Population In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients were randomised to either Sequence 1 (AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2) or Sequence 2 (AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2). 0 None 1 38 20 38 View
Part B Safety Population In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation. 2 None 7 38 37 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ATRIAL FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
LOWER RESPIRATORY TRACT INFECTION BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
NEUTROPENIC SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
PNEUMONIA PNEUMOCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
HYPONATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
INTERVERTEBRAL DISC COMPRESSION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
CANCER PAIN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
RESPIRATORY DISTRESS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
ORAL CANDIDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
PARONYCHIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
BLOOD CREATININE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
NEUTROPHIL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
MUSCULOSKELETAL CHEST PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
BALANCE DISORDER SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
DERMATITIS ACNEIFORM SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
NAIL RIDGING SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
RASH ERYTHEMATOUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
RASH MACULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
RASH MACULO-PAPULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
BLEPHARITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
CATARACT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
DRY EYE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
LACRIMATION INCREASED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
VISUAL ACUITY REDUCED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
ABDOMINAL DISTENSION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
DENTAL CARIES SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
GASTRITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
SCIATICA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
POLLAKIURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
PRODUCTIVE COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
MUSCULAR WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View