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: 2025-12-25 @ 4:27 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT01710020
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: None
Study: NCT01710020
Study Brief: Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal 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
CP-690,550 (Period 1) Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1. None None 0 12 5 12 View
CP-690,550 (Period 2) Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2. None None 0 11 4 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders COSTART View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART View
Cough increased NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders COSTART View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Ecchymosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART View