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 @ 10:56 PM
Ignite Modification Date: 2025-12-25 @ 8:24 PM
NCT ID: NCT03926169
Description: None
Frequency Threshold: 5
Time Frame: From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
Study: NCT03926169
Study Brief: A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo In Period A, participants received blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. 0 None 2 82 19 82 View
Risankizumab 360 mg In Period A, participants received blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. 0 None 2 80 26 80 View
Placebo / Risankizumab 360 mg In Period A, participants received blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60. 0 None 3 74 26 74 View
Risankizumab 180 mg In Period A, participants received blinded risankizumab 180 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. 0 None 3 80 21 80 View
Risankizumab 180 mg / Risankizumab 360 mg In Period A, participants received blinded risankizumab 180 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60. 0 None 4 70 12 70 View
Risankizumab 360 mg / Risankizumab 360 mg In Period A, participants received blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60. 0 None 0 74 19 74 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANGINA UNSTABLE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
SMALL INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
COVID-19 PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
SUBCUTANEOUS ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
TONSILLITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
INTERVERTEBRAL DISC PROTRUSION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
BREAST CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
AFFECTIVE DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
INTENTIONAL SELF-INJURY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
MAJOR DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
SUICIDAL IDEATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
ENDOMETRIOSIS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
OVARIAN CYST SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
HIDRADENITIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
ABORTION INDUCED SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.0 View
DEEP VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
ECZEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
HIDRADENITIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View