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 @ 1:11 AM
Ignite Modification Date: 2025-12-25 @ 11:22 PM
NCT ID: NCT03939793
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data was collected for 6 months post-enrollment.
Study: NCT03939793
Study Brief: Using Digital Health, Financial Incentives, and Community Health Worker Support to Change Health Behavior
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care Participants randomized to the usual-care arm were asked to check their daily blood glucose and to continue with their usual care. 0 None 13 50 0 50 View
Digital Health Participants randomized to the digital health arm were asked to check their blood glucose and text the value daily to a phone number linked to the Way to Health platform. To promote early motivation and habit formation, participants were entered into a lottery each day they texted their glucose values for the first 6 weeks of the study period. Each day participants texted, the lottery provided an 18 in 100 chance of winning $5 and 1 in 100 chance of winning $50. Accrued money was distributed to participants biweekly on a reloadable card. If participants texted in a blood glucose value that was pre-established as medically dangerous (\< 60, \> 400), they received an automated text encouraging them to follow up with their provider. These values were also routed directly to the study clinician who called each patient within 24 hours to provide clinical management and coordinate care with the patient's provider. 0 None 13 50 0 50 View
Hybrid Digital Health and Community Health Worker Support Participants in the hybrid arm received all aspects of the digital health intervention. Additionally, CHWs met with participants at enrollment and provided brief coaching using positive affect induction and attribution retraining to increase resilience to setbacks. At this meeting, CHWs explained to patients that they might work with them in the future if they needed additional support. During the first 12 weeks of the study, hybrid arm participants with low rates of SMBG (defined as 5 instances of missed readings) and/or elevated glucose readings (defined as a glucose level \> 300 mg/dL for \> 30% of days over any 2-week period) were 'escalated' to receive intensive CHW support. CHWs implemented the IMPaCT intervention, in which the CHW used an in-depth semi-structured interview guide to get to know participants' strengths, goals, and unmet social needs. Participants' individualized goals became the basis for tailored action plans. For the remainder of the 24-week study period, CHWs provided coaching, social support, advocacy, and navigation to support participants in achieving their health goals. CHWs communicated with participants at least once per week, including monthly face-to-face contact. CHWs normalized setbacks and used positive affect induction and attribution retraining to help patients to cope with failure. CHWs also helped participants connect to long-term family and social supports after the intervention ended. 0 None 14 50 0 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Volume Overload SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diabetic Ketoacidosis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Altered mental status SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Finger infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diabetic foot infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Post-operative pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ankle fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteomyelitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subarachnoid hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intrauterine fetal demise SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pyelonephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute respiratory failure with hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders None View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):