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 @ 11:07 AM
Ignite Modification Date: 2025-12-26 @ 11:07 AM
NCT ID: NCT00004412
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00004412
Study Brief: Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Local Care Dressing Standard local care including cleaning, saline irrigation, dressing changes only for 8 weeks twice a week. None None 5 11 1 11 View
Arginine Butyrate Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours. None None 9 15 0 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vaso-occlusive crisis (VOC)) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Septic arthritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clotted Portacath SYSTEMATIC_ASSESSMENT Vascular disorders None View
Chronic Limb Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Head & Eye Pain NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bloody Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ulcer Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Possible Celluitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pre-existing Osteomyelitis of Left Foot SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pleural effusion and Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain , SOB SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Decreased Appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View