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 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
NCT ID:
NCT01198756
Description:
For the systematically-assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
Frequency Threshold:
5
Time Frame:
Serious adverse events were assessed from Day 0 to Day 180. Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during a 7-day and 28-day post-vaccination period, respectively.
Study:
NCT01198756
Study Brief:
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in 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 |
|---|---|---|---|---|---|---|---|---|
| GSK2282512A 1 Group | Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | None | None | 3 | 932 | 731 | 932 | View |
| Victoria Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | None | None | 6 | 929 | 666 | 929 | View |
| Yamagata Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | None | None | 5 | 932 | 659 | 932 | View |
| GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age. | None | None | 7 | 301 | 233 | 301 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Anaphylactic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Angioedema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Facial bones fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Febrile convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Foreign body | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Gastroenteritis rotavirus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Grand mal convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Joint dislocation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Lobar pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Lymphadenitis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Vitello-intestinal duct remnant | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | None | View |
| Accidental overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Biliary dyskinesia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Bronchopneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hypovolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Respiratory syncytial virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Traumatic brain injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Shivering | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Redness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Loss of appetite | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Temperature | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Joint pain at other location | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Muscle aches | SYSTEMATIC_ASSESSMENT | General disorders | None | View |