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 @ 9:23 PM
Ignite Modification Date: 2025-12-25 @ 7:09 PM
NCT ID: NCT00914732
Description: Reactogenicity symptoms solicited on the memory aid are counted as an event if occurring at any time during the 15 day period
Frequency Threshold: 5
Time Frame: Solicited reactogenicity symptoms were collected on memory aid for 15 days after each vaccination. Non-serious unsolicited adverse events were collected for 28 days after each vaccination. Serious adverse events were collected through 180 days after the second vaccination.
Study: NCT00914732
Study Brief: Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lyophilized, Subcutaneous Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28. 0 None 1 165 164 165 View
Liquid, Subcutaneous Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28. 0 None 2 167 161 167 View
Liquid, Intradermal Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28. 0 None 1 191 191 191 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (14.0) View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View
Colitis ischaemic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Myalgia SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Appetite disorder SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (14.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (14.0) View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Axillary pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Vaccination Site Discolouration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Vaccination Site Haematoma NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Vaccination Site Nodule NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Oropharyngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (14.0) View