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 @ 4:10 AM
Ignite Modification Date: 2025-12-26 @ 3:08 AM
NCT ID: NCT03007420
Description: Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
Frequency Threshold: 0
Time Frame: Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Study: NCT03007420
Study Brief: A Prospective Controlled Treatment Trial for Post-Traumatic Headaches
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cervical Medial Branch Block_Initial Treatment This arm/group represents the total number of patients who were randomized to the cervical medial branch block treatment at the start of the study. 0 None 0 8 8 8 View
Crossover to ONB From Initial CMBB This arm/group represents the total number of patients who were initially randomized to the cervical medial branch block treatment at the start of the study but then crossed over to the occipital nerve block treatment arm. 0 None 0 2 2 2 View
Crossover to CMBB From Initial ONB This arm/group represents the total number of patients who were initially randomized to the occipital nerve block treatment at the start of the study but then crossed over to the cervical medial branch block treatment arm. 0 None 0 3 3 3 View
Occipital Nerve Block_Initial Treatment This arm/group represents the total number of patients who were randomized to the occipital nerve block treatment at the start of the study. 0 None 0 8 8 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain at the site of injection SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bleeding from the site of injection SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Infection (warmth, redness, swelling) at the site of injection SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Neck stiffness SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Muscle soreness/pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Dizziness SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Upper limb numbness/weakness SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Fatigue SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Gait instability or balance problems SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Difficulty swallowing SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View