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 @ 1:19 AM
Ignite Modification Date: 2025-12-25 @ 11:27 PM
NCT ID: NCT00857493
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00857493
Study Brief: A Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-experienced Subjects
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 IMVAMUNE: Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose 0 None 2 62 21 62 View
Group 2 IMVAMUNE: One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 0 None 2 58 21 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Application site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Injection site nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View