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 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:01 PM
NCT ID:
NCT03929757
Description:
The full analysis set included all participants with at least one study intervention administration documented.
Frequency Threshold:
5
Time Frame:
Main study: Up to Day 365 ; Extension study: Up to extension Day 85
Study:
NCT03929757
Study Brief:
A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Main Study: Ad26.ZEBOV+MVA-BN-Filo+MenACWY | Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1\*10\^8 infectious units \[Inf U\]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237. | 0 | None | 10 | 75 | 58 | 75 | View |
| Main Study: MenACWY (Control Arm) | Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237. | 0 | None | 4 | 33 | 26 | 33 | View |
| Extension Study: Ad26.ZEBOV+MVA-BN-Filo | Participants who were originally randomized to the control arm and who had not withdrawn during the main study entered the extension phase to receive 0.5 mL of Ad26.ZEBOV vaccine (5\*10\^10 vp) on Day 1 by IM injection followed by 0.5 mL of MVA-BN-Filo (1\*10\^8 Inf U) vaccine by IM injection on Day 57. Participants were also followed-up for safety until 28 days post-dose 2, that is, Day 85. | 0 | None | 0 | 26 | 9 | 26 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Gastrointestinal Candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Malaria | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Measles | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Malnutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hypovolaemic Shock | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Acarodermatitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Conjunctivitis Bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Furuncle | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Gastrointestinal Candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Helminthic Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Malaria | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Oral Candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Rhinitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |
| Dermatitis Diaper | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 | View |