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 @ 3:20 PM
Ignite Modification Date: 2025-12-25 @ 1:40 PM
NCT ID: NCT03058692
Description: For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
Frequency Threshold: 5
Time Frame: Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
Study: NCT03058692
Study Brief: Two Doses of Multimeric-001 (M-001) Followed by Influenza Vaccine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
M-001 + IIV4 0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172 0 None 1 61 52 61 View
Placebo + IIV4 0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172 0 None 0 59 44 59 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deafness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (21.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.1) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.1) View
Feeling Hot SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.1) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.1) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.1) View
Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.1) View
Haemoglobin Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.1) View
White Blood Cell Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.1) View
White Blood Cell Count Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.1) View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.1) View
Injection Site Haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.1) View
Injection Site Induration SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.1) View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.1) View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.1) View