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 @ 7:42 PM
Ignite Modification Date: 2025-12-25 @ 5:21 PM
NCT ID: NCT01988103
Description: None
Frequency Threshold: 5
Time Frame: AEs are reported for the 16-week placebo-controlled phase and up to 68 weeks for those who received apremilast during the study; TEAEs were recorded from the date of the first dose of IP received to no later than 28 days after the last dose of IP
Study: NCT01988103
Study Brief: Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis
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 (Weeks 0-16) Participants initially randomized to identically matching placebo (PBO) by mouth (PO) twice a day (BID) during the Placebo-controlled Phase (Weeks 0-16). None None 0 84 9 84 View
Apremilast 20mg BID (Weeks 0-16) Participants initially randomized to receive apremilast 20 mg BID PO during the Placebo-controlled Phase (Weeks 0-16). None None 4 85 16 85 View
Apremilast 30mg BID (Weeks 0-16) Participants initially randomized to apremilast 30 mg BID PO during the Placebo-controlled Phase (Weeks 0-16). None None 0 85 18 85 View
Apremilast 20mg BID (Weeks 0-68) Participants who received 20 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 up until Week 68. None None 11 121 35 121 View
Apremilast 30mg BID (Weeks 0-68) Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 up until Week 68 None None 2 120 40 120 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Periodontitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Colon cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Renal infarct SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View