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 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
NCT ID:
NCT03003403
Description:
We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Frequency Threshold:
0
Time Frame:
Randomization through 12 months (active intervention phase)
Study:
NCT03003403
Study Brief:
Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intervention Program | Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dietitians serving as health coaches within a local network of community health centers. Intervention Program: Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training. | 0 | None | 22 | 223 | 42 | 223 | View |
| Usual Care Program | Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information. | 0 | None | 13 | 220 | 34 | 220 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Severe abdominal pain, discomfort, symptoms | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Motor vehicle accident; fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Bone fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cysts/Polyps requiring cancer treatment/other intervention | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Parkinson's related complications | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Breathing complications (asthma, COVID19, infections) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Surgical procedures for heart/GI | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Psychosis | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Diabetes related complications | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Kidney and urinary tract infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hypertension-related complications | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Skin infections | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| General infectious diseases | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypertension-related issues | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Minor falls | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Eye infections | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Minor UTIs | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Minor stomach pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Sprains/strains | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Minor nerve pain/issues | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Neoplasms/cysts | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Psychiatric condition (due to lack of medication) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Shortness of breath, minor respiratory infections | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Uterine fibroid | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Diabetes-related complications | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Minor outpatient surgical procedures | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Misc non-systemic infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |