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 @ 2:47 PM
Ignite Modification Date: 2025-12-25 @ 1:15 PM
NCT ID: NCT00866359
Description: 108 participants were part of the follow-up phase (had prematurely discontinued therapy during the placebo (PBO)-controlled phase but had completed PBO-controlled phase and prematurely discontinued therapy during the extension phase. Those who prematurely discontinued therapy during the PBO-controlled phase did not participate the extension phase
Frequency Threshold: 5
Time Frame: Days 1 to Day 197 visit; maximum exposure to study drug was 25.1 weeks. From Day 1 (first dose) through the end of the follow up period up to 28 days after the last dose of study drug.
Study: NCT00866359
Study Brief: A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Week 12: Placebo BID Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 12 for all participants randomized to placebo. None None 3 56 48 56 View
Week 12: Apremilast 30 mg BID Participants randomized to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase. Includes data through Week 12 for all participants randomized to 30mg Apremilast BID. None None 2 55 47 55 View
Week 24: Apremilast 30 mg BID Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, or 12), up until Week 24. Includes data through Week 24 for participants who were treated with Apremilast started at Week 0 and data from Week 12 through Week 24 for participants who were treated with Apremilast started at Week 12. None None 6 100 82 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 14.0 View
Behçet's Syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA Version 14.0 View
Diplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 14.0 View
Anal Fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 14.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 14.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 14.0 View
Oral Herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 14.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 14.0 View
Iron Deficiency Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 14.0 View
Behçet's Syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA Version 14.0 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 14.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 14.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 14.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.0 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.0 View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 14.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 14.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 14.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 14.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 14.0 View
Fibromyalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 14.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 14.0 View