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 @ 3:24 AM
Ignite Modification Date: 2025-12-26 @ 2:04 AM
NCT ID: NCT01162005
Description: None
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT01162005
Study Brief: Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SDNS/FRNS Group Indicative of two or more relapses during tapering or within 14 days of stopping steroid therapy or more than four relapses within one year or at least two within six months 0 None 0 44 3 44 View
SRNS Group Absence of remission after four weeks of steroid therapy 0 None 4 33 16 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Decreased renal function SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Transient glycosuria NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastrointestinal trouble NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient hyperglycemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Itching sensation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View