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 @ 9:36 PM
Ignite Modification Date: 2025-12-25 @ 7:20 PM
NCT ID: NCT03527732
Description: Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.
Frequency Threshold: 0
Time Frame: Adverse events were assessed 3h and 24h post treatment.
Study: NCT03527732
Study Brief: Efficacy and Safety of IVM/ALB Co-administration
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 in Côte d'Ivoire 400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire 0 None 0 254 83 254 View
Albendazole and Ivermectin in Côte d'Ivoire 400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire 0 None 0 254 99 254 View
Albendazole in Laos 400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos 0 None 0 273 77 273 View
Albendazole and Ivermectin in Laos 400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos 0 None 0 273 72 273 View
Albendazole in Pemba Island 400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island 0 None 0 305 28 305 View
Albendazole and Ivermectin in Pemba Island 400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island 0 None 0 308 18 308 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Allergic reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View