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 @ 5:19 PM
Ignite Modification Date:
2025-12-25 @ 2:55 PM
NCT ID:
NCT05079750
Description:
None
Frequency Threshold:
0
Time Frame:
Solicited local and systemic AEs were collected 7 days post each vaccination. Unsolicited adverse events were collected 28 days post each vaccination. Serious adverse events and adverse events of special interest were collected for each volunteer from their enrolment to their final visit.
Study:
NCT05079750
Study Brief:
A Study of a New Vaccine Against Two Types of Ebola
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group 1: Low Dose | n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^9 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably) | 0 | None | 1 | 6 | 6 | 6 | View |
| Group 2: Mid Dose | n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably) | 0 | None | 0 | 6 | 5 | 6 | View |
| Group 3: High Dose 1 | n=14 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^10 vp ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably) | 0 | None | 0 | 14 | 12 | 14 | View |
| Group 4: High Dose 2 | n=7 participants vaccinated with a second dose of ChAdOx1 biEBOV 5x10\^10 vp twelve weeks after the first ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably) | 0 | None | 0 | 7 | 5 | 7 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Endometriotic cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (24.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Solicited local AEs | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Solicited systemic AEs | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (24.0) | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Aphthous ucler | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Tongue ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Axillary pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Hordoleum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Joint swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Muscle fatigue | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Limb discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Dysmenorrhea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Rhinorrhea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Seasonal allergy | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Sneezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Injection site dryness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Vessel puncture site bruise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Increased viscosity of upper respiratory tract | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |