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 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:32 PM
NCT ID:
NCT01001169
Description:
None
Frequency Threshold:
5
Time Frame:
Solicited local and general symptoms: during the 7-day (Day 0-6) post-vaccination period; Unsolicited AEs: up to 84 days (Days 0-83) after the first vaccination; SAEs: during the entire study period (from Day 0 up to Day 182).
Study:
NCT01001169
Study Brief:
Safety and Immunogenocity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Japanese Children
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| GSK2340274A_F1 6M-9Y Group | Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years. | None | None | 1 | 30 | 30 | 30 | View |
| GSK2340274A_F2 10Y-17Y Group | Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule. | None | None | 1 | 30 | 30 | 30 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Redness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Drowsiness (6m-5y) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Irritability (6m-5y) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Loss of appetite (6m-5y) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Fatigue (6y-9y + 10y-17y) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Gastrointestinal (6y-9y + 10y-17y) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Headache (6y-9y + 10y-17y) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Joint pain (6y-9y + 10y-17y) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Muscle aches (6y-9y + 10y-17y) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Shivering (6y-9y + 10y-17y) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Sweating (6y-9y + 10y-17y) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Temperature (Axillary) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.0 | View |
| Axillary pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Eye discharge | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 13.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |