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 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
NCT ID:
NCT04711356
Description:
Participants were observed for at least 30 minutes after vaccination. During the first 7 days post booster, field workers visited participants at home daily to record local and systemic solicited AEs using a diary card. Parents or guardians of participants received a 24-hour phone number to contact in case of medical problems and were asked about the participant's health at every study visit. Unsolicited AEs were recorded from the booster vaccination until 28 days post-booster vaccination.
Frequency Threshold:
0
Time Frame:
Solicited local and systemic adverse events were recorded from the booster vaccination (day 1) to 7 days after the booster vaccination (day 8) Unsolicited adverse events were recorded from the booster vaccination (day 1) to 28 days after the booster vaccination (day 29)
Study:
NCT04711356
Study Brief:
Ad26.ZEBOV Booster in Children Previously Vaccinated With Ad26.ZEBOV and MVA-BN-Filo (EBOVAC Booster Study)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Study Intervention | Ad26.ZEBOV booster vaccination at a dose of 5x10\^10 vp, via IM injection | 0 | None | 0 | 50 | 32 | 50 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eye burns | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 23·1 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23·1 | View |
| Swollen thumb | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23·1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23·1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23·1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23·1 | View |
| Swelling | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23·1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23·1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23·1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23·1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23·1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 23·1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 23·1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 23·1 | View |
| Malaria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23·1 | View |
| Upper respiratory tract infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23·1 | View |
| Lower respiratory tract infection/pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23·1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23·1 | View |
| Worm infestation | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23·1 | View |
| Acute otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23·1 | View |
| Scabies | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23·1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23·1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 23·1 | View |
| Thrombocytopaenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 23·1 | View |
| Thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 23·1 | View |
| Leg ulcer | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 23·1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 23·1 | View |