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 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
NCT ID:
NCT02509494
Description:
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
Frequency Threshold:
5
Time Frame:
Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
Study:
NCT02509494
Study Brief:
Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731). | 0 | None | 3 | 43 | 22 | 43 | View |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57. | 1 | None | 16 | 298 | 194 | 298 | View |
| Stage 2 (>=18 Years): MenACWY, Placebo | Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57. | 0 | None | 4 | 102 | 63 | 102 | View |
| Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo | Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57. | 0 | None | 0 | 143 | 56 | 143 | View |
| Stage 2 (12-17 Years): MenACWY, Placebo | Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57. | 1 | None | 1 | 48 | 18 | 48 | View |
| Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo | Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57. | 0 | None | 5 | 144 | 69 | 144 | View |
| Stage 2 (4-11 Years): MenACWY, Placebo | Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57. | 0 | None | 0 | 48 | 21 | 48 | View |
| Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo | Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented. | 1 | None | 15 | 144 | 108 | 144 | View |
| Stage 2 (1-3 Years): MenACWY, Placebo | Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented. | 0 | None | 3 | 48 | 38 | 48 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Anaemia of Pregnancy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Iron Deficiency Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Retinal Detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 21.1 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Peptic Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Brain Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Chorioretinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Helminthic Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Malaria | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Meningitis Bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Orchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Osteomyelitis Chronic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Peritonitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Postoperative Wound Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Subcutaneous Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Typhoid Fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Abortion Induced Incomplete | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Chest Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Head Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Ligament Sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Multiple Injuries | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Open Globe Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Radius Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Skin Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.1 | View |
| Febrile Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Abortion Threatened | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | View |
| Haemorrhage in Pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | View |
| Placenta Praevia | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | View |
| Premature Labour | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | View |
| Renal Haematoma | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 21.1 | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Hypovolaemic Shock | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 21.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Peptic Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Furuncle | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Malaria | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Tinea Capitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Typhoid Fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Haemoglobin Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 21.1 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Pruritus Generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | View |