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 @ 5:14 PM
Ignite Modification Date: 2025-12-25 @ 2:52 PM
NCT ID: NCT00108550
Description: A psychiatrist-administered, semi-structured interview (Scandinavian Society of Psychopharmacological Investigators Side Effect Rating Scale, UKU), assessed 48 psychotropic drug-associated symptoms in the prior 3 days. Items rated as "present" (of at least "mild" intensity) and "possibly" or "probably" drug-induced were counted as adverse effects.
Frequency Threshold: 5
Time Frame: Participant report of adverse effects at any point during the 12-week trial.
Study: NCT00108550
Study Brief: Chronic Low Back Pain Research Project
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 Inert placebo capsules, 3 capsules three times a day for 12 weeks None None 0 53 21 53 View
Gabapentin gabapentin capsule 1200mg three times a day for 12 weeks None None 0 55 42 55 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
sleepiness SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
asthenia/fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
orthostatic dizziness SYSTEMATIC_ASSESSMENT Cardiac disorders SNOMED CT View
increased sleep SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
concentration difficulties SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
loss of balance SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
reduced sleep SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
increased dreaming SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders SNOMED CT View
decreased sexual desire SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders SNOMED CT View
micturation disturbance SYSTEMATIC_ASSESSMENT Renal and urinary disorders SNOMED CT View
anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
decreased salivation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
accomodation disturbance SYSTEMATIC_ASSESSMENT Eye disorders SNOMED CT View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
polyuria/polydipsia SYSTEMATIC_ASSESSMENT General disorders SNOMED CT View
failing memory SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
weight gain SYSTEMATIC_ASSESSMENT General disorders SNOMED CT View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View