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 @ 10:44 PM
Ignite Modification Date: 2025-12-25 @ 8:15 PM
NCT ID: NCT05166135
Description: Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Frequency Threshold: 0
Time Frame: From start of treatment until end of treatment, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Study: NCT05166135
Study Brief: Latin American Real-world Study in Acute Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Newly AML Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included. 392 None 2 518 2 518 View
R/R B-cell ALL Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included. 60 None 0 71 1 71 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Renal Failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Vancomycin infusion reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View