Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:33 AM
Ignite Modification Date: 2025-12-26 @ 1:09 AM
NCT ID: NCT02986334
Description: collected at each one of the 6 visits
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT02986334
Study Brief: Placebo In Chronic Back Pain (Phase 2)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
No Treatment Intervention Observational Subjects randomized to this arm will be asked to discontinue their current pain medications for the length of the study. This arm is not blinded, as both study staff and participants will be aware that they are not receiving a study treatment. 0 None 0 14 9 14 View
Active Treatment Intervention Naproxen \& Omeprazole Subjects randomized to this arm will be asked to discontinue their current pain medications and take one 500mg naproxen capsule and one 40mg omeprazole capsule twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment). Naproxen: Subjects enrolled in the active treatment arm will receive 500mg of Naproxen prescribed twice daily, once in the morning and evening. Omeprazole: Subjects enrolled in the active treatment arm will receive 20mg of Omeprazole prescribed twice daily, once in the morning and evening. Furthermore, subjects should take this one hour before a meal. 1 None 0 40 16 40 View
Placebo Treatment Intervention Subjects randomized to this arm will be asked to discontinue their current pain medications and take two placebo capsules twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment) Placebo: Subjects enrolled in the inactive treatment arm will receive two prescriptions, however, there are no active ingredients and are intended to look identical to the active treatment. Therefore, subjects will be instructed exactly the same way as if they were ingesting the active treatment. 0 None 0 40 20 40 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
pre-diabetic SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Tooth Pain SYSTEMATIC_ASSESSMENT General disorders None View
GI issues SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Seasonal allergies SYSTEMATIC_ASSESSMENT General disorders None View
pain following injection SYSTEMATIC_ASSESSMENT General disorders None View
human papillomavirus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Sore throat SYSTEMATIC_ASSESSMENT General disorders None View
Cortisone Shot in Right Hip SYSTEMATIC_ASSESSMENT General disorders None View
Cataracts SYSTEMATIC_ASSESSMENT Eye disorders None View
Cough SYSTEMATIC_ASSESSMENT General disorders None View
Cold SYSTEMATIC_ASSESSMENT General disorders None View
Cervical Cancer screening SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flu SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
High blood pressure SYSTEMATIC_ASSESSMENT General disorders None View
Puncture Bruising SYSTEMATIC_ASSESSMENT General disorders None View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Kidney Stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Acute pain in left latissimus dorsi SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Body Aches SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Acute infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Molar tooth extraction SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
upset stomach SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Appetite Loss SYSTEMATIC_ASSESSMENT General disorders None View
Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cyst removal in left arm SYSTEMATIC_ASSESSMENT General disorders None View
Right Latissimi dorsi Pain SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cystourethroscopy Procedure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Left shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View