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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
NCT ID:
NCT03617458
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse events were collected over study duration-baseline to 12-weeks.
Study:
NCT03617458
Study Brief:
Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo + Usual Care | Patient will receive non active medicine and routine medical care. Placebo: A treatment with no active ingredients or therapeutic effect. Usual Care: Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network. | 0 | None | 3 | 17 | 7 | 17 | View |
| Metformin + Usual Care | Patient will receive active ingredient medicine with routine medical care. Subjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po BID x 5 days, 500mg po TID x 5 days,1000mg po BID x 69 days (12 weeks total). Metformin: Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2. Usual Care: Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network. | 0 | None | 1 | 19 | 14 | 19 | View |
| Placebo + mHealth Intervention | Patient will receive non active medicine and the mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue. Placebo: A treatment with no active ingredients or therapeutic effect. mHealth Intervention: Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue. | 0 | None | 1 | 19 | 9 | 19 | View |
| Metformin + mHealth Intervention | Patients will receive active ingredient medicine with mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue. Subjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po twice a day (BID) x 5 days, 500mg by mouth (po) three times a day (TID) x 5 days,1000mg po BID x 69 days (12 weeks total). Metformin: Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2. mHealth Intervention: Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue. | 0 | None | 5 | 18 | 9 | 18 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Intravenous Medication Line Malfunction/Infection | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Biliary Colic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Supraventriculartachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Infections requiring Hospitalization | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastrointestinal Bleed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Clinical Worsening | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal Issues | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Intravenous Medication Line Malfunction/Infection | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Common Pulmonary Hypertension Symptoms | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| General Infection | SYSTEMATIC_ASSESSMENT | General disorders | None | View |