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: NCT01951105
Description: None
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT01951105
Study Brief: Effect of L-dopa In Subacute Back Pain Population
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Observation Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up. 0 None 0 11 0 11 View
Carbidopa/Levodopa & Naproxen Individuals identified as having a persisting phenotype were randomized to oral Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response throughout the 12 week treatment period (12.5mg/50mg, 25mg/100mg, 50mg/200mg Carbidopa/Levodopa TID). Naproxen (250mg) capsules were administered orally, one capsule TID, throughout the 12 week treatment period. 1 None 3 31 17 31 View
Placebo & Naproxen Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks. 0 None 0 30 14 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Esophageal varices SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsening angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Miscarriage SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lower gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Lower respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Influenza SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View