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:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
NCT ID:
NCT00980005
Description:
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
Frequency Threshold:
5
Time Frame:
Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Study:
NCT00980005
Study Brief:
Study to Assess the Immunogenicity and Safety of an Investigational 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 |
|---|---|---|---|---|---|---|---|---|
| Flulaval Group | subjects received Flulaval™ vaccine according to their priming status and age: * 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 * 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | None | None | 10 | 1055 | 742 | 1055 | View |
| Fluzone Group | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: * 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 * 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. | None | None | 6 | 1061 | 710 | 1061 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Herpangina | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Attention deficit/hyperactivity disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Forearm fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Oppositional defiant disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Sinus polyp | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Type 1 diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Affective disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| H1N1 influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Muscle aches | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Shivering | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Loss of appetite | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Redness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Temperature | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | None | View |