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 @ 12:40 AM
Ignite Modification Date: 2025-12-25 @ 10:52 PM
NCT ID: NCT06303167
Description: All patients enrolled were included in the all-cause mortality analysis. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Frequency Threshold: 5
Time Frame: Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
Study: NCT06303167
Study Brief: Testing AZD9291 as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH-Subprotocol E)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Osimertinib) Patients receive osimertinib (AZD9291) 80 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO or MUGA during screening, and biopsy and collection of blood samples on trial and at end of treatment. 14 None 2 17 13 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Photosensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Muscle weakness right-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View