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 @ 6:28 PM
Ignite Modification Date: 2025-12-25 @ 3:58 PM
NCT ID: NCT01225068
Description: None
Frequency Threshold: 5
Time Frame: baseline to 8 weeks after randomization
Study: NCT01225068
Study Brief: Effect of Milnacipran in Chronic Neuropathic Low Back Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Milnacipran Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6. None None 0 20 14 20 View
Placebo Placebo treatment group None None 1 20 10 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
colon resection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
headache SYSTEMATIC_ASSESSMENT General disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
sexual dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
insomnia SYSTEMATIC_ASSESSMENT General disorders None View