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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT01396512
Description:
None
Frequency Threshold:
5.00
Time Frame:
Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Study:
NCT01396512
Study Brief:
Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| IMOJEV™ Vaccine Group | Participants age 12 to 24 months received one dose of IMOJEV™ | None | None | 17 | 137 | 74 | 137 | View |
| CD.JEVAX™ Vaccine Group | Participants age 12 to 24 months received one dose of CD.JEVAX™ | None | None | 18 | 137 | 69 | 137 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| Intussusception | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Hepatitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 13.0 | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Croup infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Hand foot and mouth disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Herpangina | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Lymph node abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Meningitis aseptic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Pharyngotonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Febrile convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| Kawasaki's disease | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.0 | View |
| Rhinorrhea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | View |
| Injection site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Injection site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Injection site Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.0 | View |
| Crying Abnormal | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.0 | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.0 | View |
| Appetite Loss | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.0 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.0 | View |