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: 2025-12-26 @ 10:57 AM
Ignite Modification Date: 2025-12-26 @ 10:57 AM
NCT ID: NCT01001208
Description: The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Frequency Threshold: 5
Time Frame: 52 weeks
Study: NCT01001208
Study Brief: The Efficacy and Safety of Adding Methotrexate to Etanercept in 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
Etanercept + Placebo Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen. None None 3 239 58 239 View
Etanercept + Methotrexate Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period. None None 2 239 67 239 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Pneumonia Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Lumbar Spinal Stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Synovial Cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View