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 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
NCT ID:
NCT00249769
Description:
None
Frequency Threshold:
0
Time Frame:
1 month for serious adverse events and 7 days for non-serious adverse events
Study:
NCT00249769
Study Brief:
Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| LJEV Then MV | Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later. | 0 | None | 5 | 100 | 34 | 100 | View |
| LJEV and MV | Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age. | 0 | None | 0 | 236 | 43 | 236 | View |
| MV Then LJEV | Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later. | 0 | None | 7 | 235 | 78 | 235 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Amoebiasis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Animal bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Acute Gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Complex Febrile Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Bronchial Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Acute gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Acute otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Acute rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Acute Tonsillopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Atopic dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Bacterial conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Bronchial asthma | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Enteric fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Impetigo contagious | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Infected wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Insect bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Intestinal parasitism | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Maculo-papular lesions | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Miliaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Post-extraction hematoma | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Post-vaccination reaction | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Roseola infantum | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Systemic viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Viral conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Furuncle | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |