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 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
NCT ID:
NCT03158051
Description:
Participants were asked about Adverse Events (AE) during all in-person visits and by phone in the follow-up call. Participants in the intervention arm were asked about ER, urgent care, hospitalizations, and blood pressure-related symptoms during health coach calls.
Frequency Threshold:
0
Time Frame:
up to 13 months
Study:
NCT03158051
Study Brief:
Young Adult Hypertension Self-Management Clinical Trial
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 | Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials. | 0 | None | 3 | 157 | 56 | 157 | View |
| Usual Clinical Care | Usual care arm participants will receive routine hypertension clinical care per their primary care provider. | 1 | None | 5 | 159 | 38 | 159 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac disorders - Other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Chest Wall Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Vascular disorders - Other | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Musculoskeletal and connective tissue disorder - Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Respiratory, thoracic and mediastinal disorders - Other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Chest pain - cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v4.0 | View |
| Endocrine disorders - Other | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE v4.0 | View |
| Gastrointestinal disorders - Other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Immune system disorders - Other | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE v4.0 | View |
| Infections and infestations - Other | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Bruising | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Metabolism and nutrition disorders - Other | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Musculoskeletal and connective tissue disorder - Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Nervous system disorders - Other | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Renal and urinary disorders - Other | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Reproductive system and breast disorders - Other | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v4.0 | View |
| Respiratory, thoracic and mediastinal disorders - Other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Skin and subcutaneous tissue disorders - Other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Social circumstances - Other | SYSTEMATIC_ASSESSMENT | Social circumstances | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE v4.0 | View |
| Vascular disorders - Other | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Cardiac disorders - Other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| General disorders and administration site conditions - Other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Injury, poisoning and procedural complications - Other | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Psychiatric disorders - Other | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| None | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |