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 @ 2:47 AM
Ignite Modification Date: 2025-12-26 @ 1:27 AM
NCT ID: NCT04594733
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected weekly from weeks 1-19.
Study: NCT04594733
Study Brief: The Effect of Minocycline and N-acetylcysteine for the 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 Participants will be randomized to 8 weeks of placebo, minimum 2 week washout period, and then 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily) followed by a final 2 week washout Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily): Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily) 0 None 0 10 5 10 View
Minocycline 200 mg Daily + NAC 1200mg Daily Participants will be randomized to 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily), minimum 2 week washout period, and then 8 weeks of placebo followed by a final 2 week washout minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo: minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo 0 None 0 14 8 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Light headedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Photosensitivity SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain with swallowing SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle Pain SYSTEMATIC_ASSESSMENT General disorders None View
Joint Pain SYSTEMATIC_ASSESSMENT General disorders None View
Joint Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Red Itchy Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Ear Ringing SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Blurry Vision SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itchiness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Facial Flushing SYSTEMATIC_ASSESSMENT General disorders None View
Sun Burn SYSTEMATIC_ASSESSMENT General disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View