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: 2025-12-25 @ 5:03 AM
Ignite Modification Date: 2025-12-26 @ 4:05 AM
NCT ID: NCT00657618
Description: Safety of Pentostam was evaluated through daily assessment of AEs. Clinical lab tests including serum chemistry (glucose, electrolytes, blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase\], total bilirubin, alkaline phosphatase\], amylase, and lipase) and hematology (hemoglobin, hematocrit, platelets, and white blood cells with differential); vital signs measurements; electrocardiograms); and physical examinations were performed at screening and prior to infusion
Frequency Threshold: 0
Time Frame: prior to infusion on days (± 2) 5, 10, 15, 20, 25, and 28
Study: NCT00657618
Study Brief: Use of Sodium Stibogluconate as a Treatment for Leishmaniasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Only All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG). Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days. 0 None 8 74 32 74 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Elevated lipase/aysmpotmatic chemical pancreatitis SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Chemical hepatitis SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Allergic reaction with atypical presentation SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (Unspecified) View
Misdiagnosis SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (Unspecified) View
Hospitalization for unhealed lesion SYSTEMATIC_ASSESSMENT Product Issues MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (Unspecified) View
Subtle ECG changes SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Elevation of amylase and lipase SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Misdiagnosis SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Decreased white blood cell count SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Nephrotoxicity SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Chemical pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Myalgia/arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Elevated liver-assocated enzymes SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View