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 @ 7:39 PM
Ignite Modification Date: 2025-12-25 @ 5:19 PM
NCT ID: NCT00850603
Description: None
Frequency Threshold: 5
Time Frame: Adverse events data were collected from the day of vaccination for 28 days post-vaccination
Study: NCT00850603
Study Brief: Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
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 Subcutaneous Menomune® Participants received 0.5 mL Subcutaneous Menomune® None None 0 34 8 34 View
0.1 mL Subcutaneous Menomune® Participants received 0.1 mL Subcutaneous Menomune® None None 1 34 9 34 View
0.05 mL Intradermal Menomune® Participants received 0.05 mL Intradermal Menomune® None None 0 34 9 34 View
0.15 mL Intradermal Menomune® Participants received 0.15 mL Intradermal Menomune® None None 0 34 18 34 View
0.1 mL Intradermal Menomune® Participants received 0.1 mL Intradermal Menomune® None None 0 34 10 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chills SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 6.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 6.0 View
Injection site tenderness SYSTEMATIC_ASSESSMENT General disorders MedDRA 6.0 View
Injection site redness SYSTEMATIC_ASSESSMENT General disorders MedDRA 6.0 View