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 @ 5:57 PM
Ignite Modification Date: 2025-12-25 @ 3:20 PM
NCT ID: NCT04732468
Description: For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
Frequency Threshold: 5
Time Frame: Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
Study: NCT04732468
Study Brief: COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA
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 4: Cohort 3 Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 10 4 10 View
Group 5: Cohort 1 Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration 0 None 0 4 2 4 View
Group 5:Cohort 2 Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration 0 None 0 10 5 10 View
Group 5: Cohort 3 Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration 0 None 0 10 5 10 View
Group 5: Cohort 4 Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration 0 None 0 4 3 4 View
Group 6: Cohort 1 Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration 0 None 0 4 1 4 View
Group 6: Cohort 2 Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration 0 None 0 10 4 10 View
Group 6: Cohort 3 Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration 0 None 0 10 4 10 View
Group 6: Cohort 4 Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration 0 None 0 4 3 4 View
Group 7: Cohort 1 Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration 0 None 0 4 0 4 View
Group 7: Cohort 2 Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration 0 None 0 10 3 10 View
Group 7:Cohort 3 Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration 0 None 0 10 4 10 View
Group 7: Cohort 4 Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration 0 None 0 4 0 4 View
Group 1: Cohort 2 Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine 0 None 1 10 8 10 View
Group 1:Cohort 3 Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine 0 None 1 10 0 10 View
Group 1:Cohort 4 Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine 0 None 0 4 3 4 View
Group 2: Cohort 2 Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine 0 None 0 10 9 10 View
Group 2: Cohort 3 Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine 0 None 0 10 7 10 View
Group 2: Cohort 4 Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine 0 None 0 4 4 4 View
Group 3:Cohort 1 Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 4 2 4 View
Group 3: Cohort 2 Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 10 5 10 View
Group 3: Cohort 3 Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 10 5 10 View
Group 3: Cohort 4 Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 4 3 4 View
Group 4: Cohort 1 Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 4 1 4 View
Group 1:Cohort 1 Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine 0 None 0 4 3 4 View
Group 2: Cohort 1 Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine 0 None 0 4 4 4 View
Group 4: Cohort 2 Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 10 4 10 View
Group 4: Cohort 4 Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration 0 None 0 4 3 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders None View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Throat tightness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Forearm Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Radius Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Ehlers-Danlos syndrome SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Gastric polyps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Swelling Face SYSTEMATIC_ASSESSMENT General disorders None View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperaesthesia teeth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ocular discomfort SYSTEMATIC_ASSESSMENT Eye disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders None View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders None View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View