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 @ 10:17 PM
Ignite Modification Date: 2025-12-25 @ 7:51 PM
NCT ID: NCT04318535
Description: Non-SAEs and SAEs were reported for Safety Analysis Set Population. Adverse events were presented treatment-wise.
Frequency Threshold: 0
Time Frame: Non-SAEs and SAEs were reported from start of study treatment (Day 1) up to Day 22
Study: NCT04318535
Study Brief: Bioequivalence (BE) Study of Test Griseofulvin 500 Milligram (mg) Tablets Versus Reference and Dose Proportionality Study of Test Griseofulvin 250 mg and 500 mg Tablets Under Fed Conditions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Griseofulvin 500 mg (T1) All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule. 0 None 0 36 0 36 View
Griseofulvin 250 mg (T2) All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule. 0 None 0 36 0 36 View
Griseofulvin 500 mg (R) All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule. 0 None 0 36 1 36 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View