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 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
NCT ID:
NCT02911818
Description:
None
Frequency Threshold:
5
Time Frame:
52-weeks post randomization for the original trial; 12-weeks for the extension trial post extension randomization
Study:
NCT02911818
Study Brief:
Lifestyle Modification and Liraglutide
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| CMS-Alone | Lifestyle counseling, as currently recommended by the CMS. CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian. | 0 | None | 2 | 50 | 21 | 50 | View |
| Multi-Component Intervention | CMS-Liraglutide plus a 1000-1200 kcal/day portion-controlled diet. CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian. Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection. Portion-Controlled Diet: A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks, beginning at week 4. | 0 | None | 3 | 50 | 44 | 50 | View |
| 12-Week Extension Study: Phentermine Group | After the 1-year trial, half the participants who join the extension study will be randomized to phentermine 15.0 mg/d in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling. CMS-recommended lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian. Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection. Phentermine 15 MG | 1 | None | 1 | 22 | 12 | 22 | View |
| 12-Week Extension Study: Placebo Group | After the 1-year trial, half the participants who join the extension study will be randomized to placebo in a double-blind fashion, while continuing to take liraglutide. They will also continue to receive monthly lifestyle counseling. CMS-recommended lifestyle counseling: 4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian. Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection. Placebo Oral Tablet | 0 | None | 0 | 23 | 11 | 23 | View |
| CMS-Liraglutide | CMS lifestyle counselling plus liraglutide. CMS-recommended lifestyle counseling: 21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian. Liraglutide 3.0mg: Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection. | 0 | None | 0 | 50 | 42 | 50 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Quadriplegic event | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Asthma Exacerbation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Heart Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Tonsillopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Lower back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Knee pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Gastroesophageal reflux disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomitting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Musculoskeletal injury | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |