Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:46 AM
Ignite Modification Date: 2025-12-25 @ 10:59 PM
NCT ID: NCT03101267
Description: SAF consisted of all participants who were vaccinated with the study drug at least once.
Frequency Threshold: 5
Time Frame: From first dose of study drug up to the end of primary study period (up to 7 days after Day 183). SAEs were collected up to 9 months after the end of primary study period (until 12 months after the final vaccination of the study drug).
Study: NCT03101267
Study Brief: A Dose-finding Study of ASP4070
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ASP4070 4 mg Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals. 0 None 2 50 47 50 View
ASP4070 1 mg Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals. 0 None 0 50 41 50 View
Placebo Participants received Placebo 8 times by intradermal vaccination at 14-day intervals. 0 None 0 50 23 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendiceal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vaccination site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Tenderness SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View