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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT00142506
Description:
None
Frequency Threshold:
2
Time Frame:
24 months
Study:
NCT00142506
Study Brief:
Study of Sildenafil Citrate During and After Radiotherapy/Hormone Therapy for Erectile Function Versus Radiotherapy/Hormone Therapy for Prostate Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Prophylactic Sildenafil Citrate With Radiotherapy | radiotherapy with hormones, questionaire assessments sildenafil citrate and questionaires: Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months. Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24. | None | None | 38 | 184 | 4 | 184 | View |
| Placebo With Radiotherapy | radiotherapy without hormones, questionaire assessments placebo tablets \& questionaires: Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy. In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months. Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherap | None | None | 15 | 106 | 1 | 106 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ALT, SGPT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| AST, SGOT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Albumin, low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Bilirubin (hyperbilirubinemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Calcium, high (hypercalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Glucose, high (hyperglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| INR | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| PTT | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Phosphate, low (hypophosphatemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTC-3.0 | View |
| Potassium, high (hyperkalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Sodium, high (hypernatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Sodium, low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Trglycrde, high (hypertriglyceridemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Cholesterol,high(hypercholestremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
| Glucose, low (hypoglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Glucose, high (hyperglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTC-3.0 | View |