Adverse Events Module

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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 @ 7:36 PM
Ignite Modification Date: 2025-12-25 @ 5:16 PM
NCT ID: NCT04710303
Description: None
Frequency Threshold: 5
Time Frame: Solicited AEs: From first dose to 1 week post final vaccine; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6. Unsolicited AEs: From first dose to 30 days post final vaccine; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6. Medically Attended AEs and Serious AEs: From first dose to 6 months post final vaccine; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6. SAEs related to treatment were reported any time, up to 1 year.
Study: NCT04710303
Study Brief: COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults
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: Cohort 1 Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 10 9 10 View
Group 1: Cohort 2 Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 11 5 11 View
Group 1: Cohort 3 Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 10 7 10 View
Group 1: Cohort 6 Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 10 2 10 View
Group 2: Cohort 1 Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 10 6 10 View
Group 2: Cohort 2 Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 11 5 11 View
Group 2: Cohort 3 Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 10 6 10 View
Group 2: Cohort 6 Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 10 4 10 View
Group 3: Cohort 1 Incidence of Unsolicited Adverse Events Through 6 Months Post Final Vaccine Administration 0 None 0 10 5 10 View
Group 3: Cohort 2 Incidence of Unsolicited Adverse Events Through 6 Months Post Final Vaccine Administration 0 None 0 11 9 11 View
Group 3: Cohort 3 Incidence of Unsolicited Adverse Events Through 6 Months Post Final Vaccine Administration 0 None 0 10 4 10 View
Group 3: Cohort 6 Incidence of Unsolicited Adverse Events Through 6 Months Post Final Vaccine Administration 0 None 0 10 6 10 View
Group 4: Cohort 1 Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration 0 None 0 10 2 10 View
Group 4: Cohort 3 Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration 0 None 0 10 2 10 View
Group 4: Cohort 6 Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration 0 None 0 10 4 10 View
Group 4: Cohort 2 Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration 0 None 0 11 3 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinalgia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
HIV infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations None View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Asymptomatic COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutrophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eye contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View