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 @ 5:24 PM
Ignite Modification Date: 2025-12-25 @ 2:59 PM
NCT ID: NCT00761150
Description: AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (ABT-712 or placebo) in the DB period.
Frequency Threshold: 5
Time Frame: AEs were recorded from the time of study drug administration to 30 days after last dose (total 12 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 16 weeks).
Study: NCT00761150
Study Brief: Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open-label ABT-712 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period). None None 1 308 169 308 View
Double-blind Placebo 2 placebo tablets, twice daily, for 4 weeks (double-blind period). None None 2 118 19 118 View
Double-blind ABT-712 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). None None 0 120 18 120 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
DIVERTICULAR PERFORATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 11.1 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 11.1 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 11.1 View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 11.1 View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 11.1 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 11.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 11.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 11.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 11.1 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 11.1 View