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 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 12:38 AM
NCT ID:
NCT03156660
Description:
Consistent with the typical definition
Frequency Threshold:
5
Time Frame:
12 months
Study:
NCT03156660
Study Brief:
Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Weight Loss Intervention (Group 2) | Look AHEAD weight loss intervention Weight loss intervention (Group 2): Participants will be asked to achieve a weight loss goal of at least 5% of their baseline weight by week 8. Intervention Components: 1. Tailored calorie and fat goals based on their baseline weight. 2. Daily dietary intake and physical activity self-monitoring using a website or app. 3. Daily weight self-monitoring on the BodyTraceTM e-scale 4. Lesson materials for each session, drawn from the Look AHEAD intensive lifestyle intervention 5. Meal replacements for two meals and one snack for 8 weeks as a method to achieve the study's calorie and fat goals and as a strategy to control portions 6. Graded physical activity goals of 175 minutes of moderate intensity exercise (e.g., brisk walking) per week, or 10,000 steps per day 7. Fit Bit Alta activity trackers to self-monitor steps | 0 | None | 14 | 110 | 84 | 110 | View |
| Weight Gain Prevention (Group 1) | Small Changes weight stability intervention Weight gain prevention (Group 1): Participants will be asked to keep their weight stable during the initial 8 weeks of the study. Intervention Components: 1. Lesson materials adapted from the Small Changes intervention, which will provide guidance for meeting the goals of this intervention (i.e., increasing steps by 2000 steps per day, making one Small dietary Change each day). 2. Daily self-monitoring of steps and number of Small Changes 3. Daily weight self-monitoring on the BodyTraceTM e-scale 4. Fit Bit Alta activity trackers to self-monitor steps | 1 | None | 17 | 109 | 88 | 109 | View |
| Self-guided Intervention (Group 3) | Self-guided weight management with the EatingWell Diet book Self-guided intervention (Group 3): Participants randomized to Group 3 will wait for 8 weeks before initiating the same smoking cessation intervention as the other two conditions, while they review the provided weight management focused book. Intervention Components: 1. EatingWell Diet book. 2. Daily weight self-monitoring on the BodyTraceTM e-scale | 0 | None | 12 | 86 | 60 | 86 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Severe distress | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Heart Attack | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Low blood pressure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Asystole | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Heart Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| COPD | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Bloodstream Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Blockage in legs, stroke, surgery | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Clavicle injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Head Injury and amnesia | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Ankle injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Pancreatic Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Lung Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Breast Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Gastrointestinal Bleeding and ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Ulcerative Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dehydration and sinus infection | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Gallbladder Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Bladder Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hysterectomy due to cervical cancer | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Knee Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Surgery for mass in large intestine | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Cerebral Spinal Fluid leak and surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Biopsy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Heart Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Back Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hip Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Foot Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Prostate Surgery (cancer) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Brain surgery (tumor) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Gastric Sleeve Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hole in Heart | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rapid Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Abdominal Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Emotional Disturbance | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| High Blood Pressure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Difficulty Sleeping | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Abnormal Dreams | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cold | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |