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 @ 11:05 PM
Ignite Modification Date: 2025-12-25 @ 8:36 PM
NCT ID: NCT04726969
Description: Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs.
Frequency Threshold: 2
Time Frame: 14-21 days
Study: NCT04726969
Study Brief: Efficacy and Safety of MOX/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
Arm C: Ivermectin and Albendazole Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin 0 None 0 86 34 86 View
Arm A: Moxidectin and Albendazole Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole 0 None 0 85 31 85 View
Arm B: Albendazole Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole 0 None 0 84 26 84 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Nausea SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Allergic reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Symptoms related to immune system activation NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (5.0) View