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 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
NCT ID:
NCT02455804
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Study:
NCT02455804
Study Brief:
NIRTRAKS Post-Market Study (NIRTRAKS)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Single Arm | This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted. Stenting procedure: All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted. | 0 | None | 40 | 65 | 58 | 65 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| cardiac disorders | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| ear and labyrinth disorders | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Eye disorders | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| General disorders and administration site conditions | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| General disorders and administration site conditions | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| hepatobiliary disorders | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Infections and infestations | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Injury, poisoning and procedural complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Investigations | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| metabolism and nutrition disorders | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| musculoskeletal and connective tissue disorders | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| neoplasms benign, malignant and unspecified | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| nervous system disorders | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| psychiatric disorders | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| renal and urinary disorders | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Respiratory, thoracic and mediastinal disorders | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin and subcutaneous tissue disorders | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Vascular disorders | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Blood and lymphatic system disorders | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood and lymphatic system disorders | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Cardiac Disorders | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| ear and labyrinth disorders | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Eye disorders | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Gastrointestinal disorders | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| General disorders and administration site conditions | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| hepatobiliary disorders | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Infections and infestations | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Injury, poisoning and procedural complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Investigations | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| metabolism and nutrition disorders | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| musculoskeletal and connective tissue disorders | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| neoplasms benign, malignant and unspecified | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| nervous system disorders | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| psychiatric disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| renal and urinary disorders | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Respiratory, thoracic and mediastinal disorders | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin and subcutaneous tissue disorders | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Vascular disorders | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |