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 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
NCT ID:
NCT04870957
Description:
In line with clinicaltrials.gov definitions.
Frequency Threshold:
5
Time Frame:
T1(Week 1) to T5 (Week 36), approximately 9 months
Study:
NCT04870957
Study Brief:
The Back Pain Consortium Research Program Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Duloxetine | Duloxetine: For days 1-7, patients will take 30mg of duloxetine once a day, in the morning. Starting day 8, participants tolerating the medication will be escalated to 60mg once a day. They will also have the option of staying at 30mg, once a day or stopping the medication. At the end of the 8-week intervention period, participants will have the option to continue the medication commercially (non-study medication) under the care of their physician or taper off the medication. During the entire 8-week intervention, patients will be asked to keep a daily log of medication dosage, any missed doses, and any side-effects they may have experienced. Pro-Diary monitor: Participants will wear during 5 separate 7-day "home monitoring" periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36. | 0 | None | 3 | 167 | 40 | 282 | View |
| Run-in Period | 5 week period leading up to randomization at T2 visit during which participants had access to the PainGuide self-managment program. | 0 | None | 9 | 494 | 4 | 494 | View |
| On Follow-Up | Participants who were on follow-up due to PGIC=1 at T2 or T3, the week between treatment 1 and 2 or post treatment 2. | 1 | None | 17 | 405 | 2 | 405 | View |
| MBSR (mindfulness-based stress reduction) | MBSR: In this group (mindfulness-based stress reduction) participants will take part in 9 group sessions. The groups sessions will be divided into 8 weekly 2-hour groups sessions and one 6-hour "retreat". During the sessions participants will practice mindfulness exercises directed by the a MBSR therapist. Additionally, participants will also be asked to practice daily formal mindfulness at home using audio recordings of 30-45 minute guided meditation exercises. These audio recordings can be accessed online. The sessions may take place in-person or virtually. Pro-Diary monitor: Participants will wear during 5 separate 7-day "home monitoring" periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36. | 1 | None | 5 | 182 | 1 | 182 | View |
| PT and exercise | PT and exercise: Participants will take part in 10 physical therapy visits over the course of 8 weeks. Participants will meet with the physical therapist twice a week for a 1-hour session for weeks 1 and 2 and then weekly for the remaining 6 weeks. The physical therapist will tailor a program to the participant's needs according to recommended PT practice guidelines that will include in-person treatment, home exercise prescription, and encouragement of progressive, low-intensity, submaximal fitness and endurance activities, such as walking. Participants will be given a home program of exercises to be done daily and asked to engage in daily walking with a set goal based on the individual's capacity and current fitness level. Walking was selected as the aerobic exercise of focus for this treatment because it is recommended for patients with all levels of pain severity, is highly feasible to complete, and has shown effects on outcomes such as pain and disability. Pro-Diary monitor: Participants will wear during 5 separate 7-day "home monitoring" periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36. | 0 | None | 8 | 175 | 1 | 175 | View |
| Acupressure | Self -administered acupressure: A device called the "AcuWand" will be used to administer the self-acupressure intervention for approximately 30 minutes daily for 8 weeks. Participants will use a mobile application (app) called "MeTime" that will have daily instructions on how to use the AcuWand. Research staff will show participants how to use the AcuWand and MeTime app. In addition, participants will keep a daily log to track at-home acupressure sessions. Pro-Diary monitor: Participants will wear during 5 separate 7-day "home monitoring" periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36. | 0 | None | 6 | 202 | 0 | 202 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Knee Replacement | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| None | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Car Accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Squamous Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Pacemaker | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Dizziness and Tingling Limbs | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| COPD Exacerbation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Nose Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hip Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Dermatomyositis | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| COVID | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hernia Repair | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Cholecystectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Thrombectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Shortness of Breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cardiac Seizure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Failure to Thrive | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Lumbar Fusion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| DVT | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| TKA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Thyroplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Wrist Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Finger Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hysterectomy | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| TIA | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Breast Cancer | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |