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 @ 2:39 AM
Ignite Modification Date: 2025-12-26 @ 1:17 AM
NCT ID: NCT00596934
Description: Adverse event data collected from patient's baseline study appointment till one month following patient's 12 month study appointment.
Frequency Threshold: 0
Time Frame: 13 months from patient baseline appointment.
Study: NCT00596934
Study Brief: Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metreleptin Treatment Arm Treatment group metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections None None 1 9 1 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
toxoplasmosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
left side muscle pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
vertigo NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
polyuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
actinic keratoses NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
rectal pressure with ejaculation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
right sternocleidomastoid lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
right axilla lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View