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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
NCT ID:
NCT04495894
Description:
None
Frequency Threshold:
0
Time Frame:
Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
Study:
NCT04495894
Study Brief:
Pre-Incisional Ketorolac for Patients Undergoing Surgery for Non-Small Cell Lung Cancer and Renal Cell Carcinoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC) | Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision. | 0 | None | 2 | 14 | 6 | 14 | View |
| Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC) | Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints. | 0 | None | 0 | 6 | 1 | 6 | View |
| Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC) | Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision. | 0 | None | 1 | 28 | 16 | 28 | View |
| Control Group For Participants With Renal Cell Carcinoma (RCC) | Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints. | 0 | None | 2 | 10 | 6 | 10 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Elevated cardiac troponin | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Subcutaneous emphysema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hematoma | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Thrombophlebitis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea/vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Esophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Belching/bloating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Bowel obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pneumoperitoneum | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Allergic reaction to oxycodone | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| External ear pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Itching | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Numbness (right hand) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| High chest tube output | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Persistent air leak | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Atelectasis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Shortness of breath | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Rib cage pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Low urine output | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |