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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:53 PM
NCT ID: NCT00258856
Description: None
Frequency Threshold: 5.0
Time Frame: 28 days post-vaccination
Study: NCT00258856
Study Brief: Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or 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
Menactra® Group 1 Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination None None 0 58 13 58 View
Menactra® Group 2 Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination None None 0 58 20 58 View
Meningococcal Vaccine-naïve Group 3 Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination. None None 0 58 14 58 View
Meningococcal Vaccine-naïve Group 4 Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination None None 0 59 15 59 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 7.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 7.1 View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 7.1 View
Upper respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 7.1 View