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 @ 4:03 AM
Ignite Modification Date: 2025-12-26 @ 2:57 AM
NCT ID: NCT00316602
Description: None
Frequency Threshold: 2
Time Frame: 32 weeks
Study: NCT00316602
Study Brief: A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Healthy Participants Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE) 0 None 3 282 133 282 View
Atopic Dermatitis Participants Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] ≤ 30) 0 None 3 350 196 350 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Extraocular muscle paresis SYSTEMATIC_ASSESSMENT Eye disorders None View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Loss of consciousness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Neurosis SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders None View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders None View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders None View
Troponin I increased SYSTEMATIC_ASSESSMENT Investigations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngotonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View