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: 2025-12-26 @ 11:49 AM
Ignite Modification Date: 2025-12-26 @ 11:49 AM
NCT ID: NCT01680016
Description: Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
Frequency Threshold: 5
Time Frame: Whole study period (From day 1 to day 43)
Study: NCT01680016
Study Brief: A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zagreb(≥6 to ≤17 Years) ≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22 None None 0 121 64 121 View
Essen(≥6 to ≤17 Years) ≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29 None None 0 119 63 119 View
Zagreb(≥51 Years) ≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22 None None 1 200 19 200 View
Essen(≥51 Years) ≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29 None None 0 200 24 200 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancreatitis Acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0v View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0v View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0v View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0v View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0v View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0v View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0v View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0v View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0v View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0v View