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 @ 2:28 PM
Ignite Modification Date: 2025-12-25 @ 1:03 PM
NCT ID: NCT02180659
Description: For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
Frequency Threshold: 1.15
Time Frame: All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
Study: NCT02180659
Study Brief: A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Buprenorphine Tablets + Placebo Implants Daily SL BPN tablets (≤8 mg/daily) + four placebo implants sublingual buprenorphine tablets placebo implants None None 3 89 4 89 View
Buprenorphine Implants + Placebo Tablets Four 80 mg Probuphine implants + daily SL placebo tablets Buprenorphine implant sublingual placebo tablets None None 2 87 1 87 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Biliary Colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bipolar I Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cholecystitis Chronic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Muscle spasm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abortion - Spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Pediatric exposure to treatment SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View