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 @ 1:47 AM
Ignite Modification Date: 2025-12-26 @ 12:05 AM
NCT ID: NCT03007394
Description: 1. The "Intent-to-Treat (ITT) Population" of 272 are all subjects who may have taken at least one dose of lorcaserin or placebo after randomization as noted in the total for the participant flow. 2. The "PPEE Population" of 242 is the subset of the ITT Population who pre-qualify for the primary efficacy endpoint by meeting the specified PPEE criteria prior to randomization, which is the subset population used here
Frequency Threshold: 2
Time Frame: Adverse event data were collected every week during treatment and through study follow-up, a 13-week treatment phase with a 4-week follow-up period.
Study: NCT03007394
Study Brief: Lorcaserin in the Treatment of Cocaine Use Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Oral Capsule 10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule 0 None 6 124 69 124 View
Lorcaserin 10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule 0 None 4 118 66 118 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT General disorders None View
Life threatening and hospitalization SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Life threatening and hospitalization SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood pressure increase/decrease SYSTEMATIC_ASSESSMENT Investigations None View
Abdominal Distress SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Body pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Depression/Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bodily injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View