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 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
NCT ID:
NCT00514904
Description:
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Frequency Threshold:
5
Time Frame:
Serious adverse events: from Day 0 up to 6 months after vaccination. Solicited symptoms: during the 4-day (Day 0-Day 3) follow-up period after vaccination.
Study:
NCT00514904
Study Brief:
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old 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 |
|---|---|---|---|---|---|---|---|---|
| Nimenrix Group | Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | 0 | None | 15 | 1125 | 416 | 1125 | View |
| Mencevax ACWY Group | Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm. | 0 | None | 7 | 376 | 155 | 376 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Hyperchlorhydria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.0 | View |
| Typhoid fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Hyperchlorhydria | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Food intolerance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Dengue fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Amoebic dysentery | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Parasitic gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Pharyngotonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pain (< 6 years of age) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Redness (< 6 years of age) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Swelling (< 6 years of age) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Pain (≥ 6 years of age) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Redness (≥ 6 years of age) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Swelling (≥ 6 years of age) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Fever (Orally) (< 6 years of age) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Loss of appetite | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Fever (Orally) (≥ 6 years of age) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |