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 @ 2:47 PM
Ignite Modification Date: 2025-12-25 @ 1:15 PM
NCT ID: NCT06201559
Description: Safety Population included all randomized participants who received at least 1 dose of study medication. Each participant was counted once throughout the study for this analysis.
Frequency Threshold: 0
Time Frame: All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected through the entire study duration of up to a maximum of 22 days.
Study: NCT06201559
Study Brief: Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants 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
Albendazole 400mg- Reference (R) Participants received a single oral dose of 400 mg Albendazole tablet under fed conditions on Day 1 in either treatment Periods 1, 2, 3 and 4. 0 None 0 68 6 68 View
Albendazole IP 400mg- Test (T) Participants received a single oral dose of 400 mg Albendazole Indian Pharmacopoeia (IP) tablet under fed conditions on Day 1 in either treatment Periods 1, 2, 3 and 4. 0 None 1 67 6 67 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View