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 @ 4:02 PM
Ignite Modification Date: 2025-12-25 @ 2:04 PM
NCT ID: NCT03145766
Description: Analysis was performed on SafAS. A SR was an AE that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of diagnosis and/or onset post-vaccination.
Frequency Threshold: 5
Time Frame: AE data were collected from Day 0 (post-vaccination 1) up to 28 days post any vaccination. SR data were collected within 7 days post any vaccination. SAE data were collected throughout the study (up to 6 months after last vaccination, i.e., up to Month 7).
Study: NCT03145766
Study Brief: Immunogenicity and Safety of a Purified Vero Rabies Vaccine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1: VRVg-2 Formulation 1 VRVg-2 formulation 1 (Low), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. 0 None 0 80 40 80 View
Group 2: VRVg-2 Formulation 2 VRVg-2 formulation 2 (Medium), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. 0 None 0 80 39 80 View
Group 4: VRVg-1 VRVg-1 initial formulation, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. 0 None 0 39 22 39 View
Group 5: Imovax Rabies Imovax Rabies, IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. 0 None 0 41 28 41 View
Group 3: VRVg-2 Formulation 3 VRVg-2 formulation 3 (High), IM injection on Days 0, 3, 7, 14 and 28. Concomitant administration of HRIG on Day 0. 0 None 1 80 45 80 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Facial Paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Application Site Bruise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View