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 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
NCT ID:
NCT02583256
Description:
The overall safety set included all subjects who were in the solicited safety set and/or in the unsolicited safety set.
Assessment of revaccination safety included:
SAEs collected between Day 1 to Day 366 Non-serious AEs included solicited AEs collected between Day 1 to Day 7 after last vaccination, and unsolicited AEs collected between Day 1 to Day 366 after last vaccination
Frequency Threshold:
5
Time Frame:
Day 1 - Day 366
Study:
NCT02583256
Study Brief:
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| aQIV-aQIV | Subjects previously vaccinated with aQIV followed one year later by aQIV Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) | 0 | None | 10 | 403 | 289 | 403 | View |
| aQIV-QIV | Subjects previously vaccinated with aQIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) | 0 | None | 11 | 403 | 269 | 403 | View |
| QIV-aQIV | Subjects previously vaccinated with QIV followed one year later by aQIV Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) | 0 | None | 7 | 402 | 274 | 402 | View |
| QIV-QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) | 0 | None | 8 | 393 | 229 | 393 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Iron Deficiency Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| Lymphadenitis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| Spina Bifida Occulta | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA version 19.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 19.1 | View |
| Aphthous Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Anaphylactic Reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA version 19.1 | View |
| Amoebic Dysentery | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Appendiceal Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Dengue Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| External Ear Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Herpangina | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Animal Bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| Jaw Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| Wound Secretion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| Febrile Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 19.1 | View |
| Kawasaki's Disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 19.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| Influenza Like Illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| Injection Site Induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 19.1 | View |
| Eating Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 19.1 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 19.1 | View |