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 @ 2:34 AM
Ignite Modification Date: 2025-12-26 @ 1:11 AM
NCT ID: NCT03676634
Description: Mortality, Adverse Events, and Serious Adverse Event definitions are as described on clinicaltrials.gov. Any anticipated or unanticipated events (not included in the serious adverse event table) grouped by organ system, with the number and frequency of such events.
Frequency Threshold: 0
Time Frame: Non-serious AEs (injection site reactions/systemic reactions) were only collected from day 0 - day 7 during the participant diary collection period. For the rest of the study (from day 7 through 12 weeks of site visits and through the week 26 follow up phone call), AEs were only collected if they were SAEs.
Study: NCT03676634
Study Brief: Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG®
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.5 mL rBV A/B A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B. 0 None 1 32 5 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View
injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v22.0 View