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 @ 1:49 PM
Ignite Modification Date: 2025-12-25 @ 12:42 PM
NCT ID: NCT01008995
Description: One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.
Frequency Threshold: 5
Time Frame: None
Study: NCT01008995
Study Brief: A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With 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 (CP) Controlled period (Week 0-12) - Placebo Group None None 1 161 21 161 View
Ustekinumab 45 mg (CP) Controlled period (Week 0-12) - Ustekinumab 45 mg Group None None 1 160 28 160 View
Placebo -> Ustekinumab 45 mg (After CP) After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -\> receiving ustekinumab 45 mg at Week 12 and Week 16 None None 2 158 27 158 View
Ustekinumab 45 mg (After CP) After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -\> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16 None None 1 159 14 159 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deafness neurosensory NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 14.0 View
Head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Psoriatic arthropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Hand fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View