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 @ 3:23 PM
Ignite Modification Date: 2025-12-25 @ 1:41 PM
NCT ID: NCT04713592
Description: None
Frequency Threshold: 5
Time Frame: All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.
Study: NCT04713592
Study Brief: Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Risankizumab/Risankizumab (Open-label Period) Participants received risankizumab injections during both the Double-blind Period and the Open-label Period. AEs and SAEs were collected from the start date of the Open-label period. 1 None 5 84 12 84 View
Placebo (Double-blind Period) Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. AEs and SAEs were collected from the time of informed consent and during the Double-blind period, as long as it did not exceed the start date of the Open-label period. 0 None 0 87 2 87 View
Risankizumab (Double-blind Period) Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. AEs and SAEs were collected from the time of informed consent and during the Double-blind period, as long as it did not exceed the start date of the Open-label period. 0 None 5 87 2 87 View
Placebo/Risankizumab (Open-label Period) Participants received placebo injections during the Double-blind Period and risankizumab injections during the Open-label Period. AEs and SAEs were collected from the start date of the Open-label period. 0 None 0 81 8 81 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANGINA UNSTABLE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
CORONARY ARTERY DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
COVID-19 PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
ACUTE RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
CARDIAC FAILURE CONGESTIVE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
TENDON RUPTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
CHRONIC OBSTRUCTIVE PULMONARY DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View