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 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
NCT ID:
NCT00197002
Description:
None
Frequency Threshold:
5
Time Frame:
Solicited local and general AEs: during the 4-day (Day 0-3); Unsolicited AEs: during the 31-day (Day 0-30); SAEs, NCIs and MSEs: during the entire study period(from Month 0 to Month 12-15/13-16).
Study:
NCT00197002
Study Brief:
Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Prevnar Havrix Group | Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10. | None | None | 10 | 175 | 121 | 149 | View |
| Havrix Group | Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9. | None | None | 6 | 177 | 107 | 147 | View |
| Havrix+Prevnar Group | Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9. | None | None | 8 | 169 | 106 | 137 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Convulsion (active phase) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Convulsion (enrollment phase) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Bronchiolitis (enrollment phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Burns second degree (enrolllment phase) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Gastroenteritis (enrollment phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Lactose intolerance (enrollment phase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Otitis media acute (enrollment phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Upper respiratory tract infection (enrollment phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Croup infectious (active phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Pneumonia (active phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Bronchial hyperactivity (active phase) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Bronchiolitis (active phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Dehydration (active phase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Developmental delay (active phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Diabetes mellitus insulin-dependent (active phase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Gait disturbance (active phase) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Hearing impaired (active phase) | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 9.1 | View |
| Hypoxia (active phase) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Kawasaki's disease (active phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Langerhans' cell granulomatosis (active phase) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | View |
| Dehydration (ESFU phase) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Gastroenteritis viral (ESFU phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Kawasaki's disease (ESFU phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Pneumonia (ESFU phase) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rhinorrhea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Fever (Axillary) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Loss of appetite | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Redness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |