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: 2025-12-24 @ 7:14 PM
Ignite Modification Date: 2025-12-25 @ 4:50 PM
NCT ID: NCT00455403
Description: None
Frequency Threshold: 5
Time Frame: 2 years 6 months
Study: NCT00455403
Study Brief: Atheroma Reduction With Chloroquine in Patients With the Metabolic Syndrome (ARCH-MS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Chloroquine Subjects Participants will receive 80 mg of chloroquine on a daily basis. Chloroquine: One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24 0 None 5 59 39 59 View
Placebo Subjects Participants will receive a placebo comparator tablet on a daily basis. Placebo Comparator: Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24 0 None 2 57 37 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Prostate Cancer NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Right Knee Replacement NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
transverse myelitis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
carotid endarterectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
cutaneous staphylococcus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
acute appendicitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
positive PPD NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
allergy/immunology NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
CNS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
ocular NON_SYSTEMATIC_ASSESSMENT Eye disorders None View