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 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:46 PM
NCT ID: NCT01220167
Description: All adverse events (AE) were recorded from the time of the first dose until the last follow-up visit scheduled 48 hours following the last dose of study intervention. Serious adverse events (SAEs) were reported from the time of the first dose until 30 days following the last dose. Subjects with AEs considered related to study drug and any SAE regardless of causality were followed until resolution of the event or the subject was lost to follow-up.
Frequency Threshold: 0
Time Frame: Adverse event data were collected from the time of the first dose until 30 days following the last dose (overall approximately 1.5 months for each subject). No adverse events were reported during the study and follow-up period. Clinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study). Thus, abnormal laboratory analytes reported as adverse events could not be attributed to any of the 3 study treatments.
Study: NCT01220167
Study Brief: Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ODFS 8 mg With and Without Water and Zofran ODT Without Water Single dose of ondansetron ODFS 8 mg film administered with and without water and Zofran 8 mg administered without water in randomized sequence. Clinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study). Thus, abnormal laboratory analytes reported as adverse events could not be attributed to any of the 3 study treatments. 0 None 0 18 4 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
White blood count increased SYSTEMATIC_ASSESSMENT Investigations None View