Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 1:33 PM
Ignite Modification Date: 2025-12-25 @ 12:34 PM
NCT ID: NCT02132195
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT02132195
Study Brief: Adrenocorticotropic Hormone (ACTH) for Frequently Relapsing and Steroid Dependent Nephrotic Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Adrenocorticotropic Hormone (ACTH) Patients will receive ACTH twice weekly subcutaneously The initial dosing will be based on body surface area (BSA): 80 IU/1.73 m2 The patients will receive the initial dose for 6 months. At 6 months, the dose will be reduced by 50%. Patients who have side effects may have the dose reduced by 50% during the initial 6 months. A second dose reduction would still occur at 6 months (25% of initial dose). ACTH: Patients will receive ACTH twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months. 0 None 3 15 4 15 View
No Treatment Patients in this treatment arm will receive no treatment to prevent relapses of nephrotic syndrome. A relapse, if it occurs, will be treated with prednisone and the patient will leave the no treatment arm of the study. 0 None 2 16 2 16 View
Rescue Therapy Patients moved from No-treatment group to receive rescue ACTH therapy twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months. Other Names: Acthar Adrenocorticotropic hormon 0 None 2 13 9 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization for renal disease relapse affecting multiple systems NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flu and strep infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Behavioral changes NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Sleep disturbances NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increase in blood pressure NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Increase in Cushingoid symptoms NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Swelling, redness, rash at injection site NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rash under arms NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View