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 @ 2:55 AM
Ignite Modification Date: 2025-12-26 @ 1:35 AM
NCT ID: NCT03726333
Description: AE information were reported by using the System Organ Class instead of preferred term to avoid the risk of re-identification of the participant.
Frequency Threshold: 5
Time Frame: From Screening (within 28 days prior to Cycle 1 Day 1) through and including at least 28 days after after the last lorlatinib dose. The duration is approximately 42 days.
Study: NCT03726333
Study Brief: Hepatic Impairment Study for Lorlatinib in Cancer 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
Group B Mild Hepatic Impairment Continued daily administration of lorlatinib in patients with mild hepatic impairment. The participant received lorlatinib 100 mg QD in Cycle 1 and lorlatinib 75 mg QD in Cycle 2. 0 None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nervous system disorders NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Psychiatric disorders NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
General disorders NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Metabolism and nutrition disorders NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Nervous system disorders NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Psychiatric disorders NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v24.1 View