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 @ 10:08 PM
Ignite Modification Date: 2025-12-25 @ 7:44 PM
NCT ID: NCT00366535
Description: None
Frequency Threshold: 0
Time Frame: The adverse event data was collected during the study period for 6 to 7 months.
Study: NCT00366535
Study Brief: Neurotropin Treatment of Fibromyalgia
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 Treatment First in G-1 This group received Placebo 4 tabs b.i.d. for the first 12 weeks. 0 None 0 56 3 56 View
Neurotropin Treatment Second in G-1 This group received Neurotropin 4 tabs b.i.d. for 12 weeks after at least 1 week "washout" period following the first 12 week interval on Placebo. 0 None 0 29 1 29 View
Neurotropin Treatment First in G-2 This group received Neurotropin 4 tabs b.i.d. for the first 12 weeks. 0 None 0 27 3 27 View
Placebo Treatment Second in G-2 This group received Placebo 4 tabs b.i.d. for 12 weeks after at least 1 week "washout" period following the first 12 week interval on Neurotropin. 0 None 0 27 1 27 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abnormality of liver function test NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Chest pain and Abnormal HB NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View