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 @ 3:33 AM
Ignite Modification Date: 2025-12-26 @ 2:15 AM
NCT ID: NCT01396005
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01396005
Study Brief: A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Methadone + Boceprevir Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg \[4 x 200 mg capsules\], orally, every 8 hours) on Days 2 through 7) None None 0 10 10 10 View
Buprenorphine/Naloxone + Boceprevir Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg \[4 x 200 mg capsules\], orally, every 8 hours) on Days 2 through 7 None None 0 11 9 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.1) View
Product taste abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.1) View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.1) View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (14.1) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.1) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.1) View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (14.1) View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (14.1) View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (14.1) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (14.1) View
Pruritus generalized SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (14.1) View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (14.1) View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.1) View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.1) View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.1) View