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: 2025-12-25 @ 2:30 AM
Ignite Modification Date: 2025-12-26 @ 1:05 AM
NCT ID: NCT04537234
Description: A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to the product administered. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on SafAS.
Frequency Threshold: 5
Time Frame: Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 (post-vaccination) up to 28 days post-vaccination.
Study: NCT04537234
Study Brief: Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Taiwanese Adults 65 Years of Age and Older
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: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. 0 None 0 82 46 82 View
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. 0 None 0 83 35 83 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
Injection Site Induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View