NCT00955929 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- 1 year
- Other-event reporting threshold
- 5%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| PRN Sildenafil | 0 / 13 | 0 / 13 | 0 / 13 |
| Nightly Sildenafil Arm | 1 / 30 | 0 / 30 | 2 / 30 |
| Combination Therapy Arm | 2 / 33 | 0 / 33 | 0 / 33 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 30
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 33
- term
- Wound complication, non-infectious
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 33
- term
- Infection w/ Gr 3/4 neut, Pelvis NOS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 33
- term
- Pain - Extremity-limb
Other reported adverse events
Complete source fields
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 13
- description
- Placebo QHS (blinded) and sildenafil 100mgs (open-label) as required for sexual relations. The placebo will be omitted on nights that 100mgs is used. Placebo will start within 24-48 hours post-surgery. Placebo QHS and sildenafil and questionnaires: Pts will be offered sildenafil 100 mg to be used before intercourse on an as-required basis. They will be given six 100 mg doses, per month, for a 12-month duration. Each patient in this group will use a placebo pill (blinded) each night, except on a nights that 100mg is taken for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
- id
- EG000
- other Num Affected
- 0
- other Num At Risk
- 13
- serious Num Affected
- 0
- serious Num At Risk
- 13
- title
- PRN Sildenafil
- deaths Num Affected
- 2
- deaths Num At Risk
- 30
- description
- Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Sildenafil and questionnaire: Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window
- id
- EG001
- other Num Affected
- 0
- other Num At Risk
- 30
- serious Num Affected
- 1
- serious Num At Risk
- 30
- title
- Nightly Sildenafil Arm
- deaths Num Affected
- 0
- deaths Num At Risk
- 33
- description
- Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL), at initial dose of 5 units (0.05ml) will be given; the first 2 injections will be done in the MSKCC urology outpatient clinic (if needed, the investigator can determine appropriate amount of injections for patient training). Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires: Intracavernous injections of a trimix combination (Papaverine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL) will be injected three times a week, and sildenafil 50mg taken on the other four (non-injection) nights. Injection therapy can be used for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
- id
- EG002
- other Num Affected
- 0
- other Num At Risk
- 33
- serious Num Affected
- 2
- serious Num At Risk
- 33
- title
- Combination Therapy Arm
- frequency Threshold
- 5
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 30
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 33
- term
- Wound complication, non-infectious
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 33
- term
- Infection w/ Gr 3/4 neut, Pelvis NOS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 33
- term
- Pain - Extremity-limb
- time Frame
- 1 year
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Preserved source evidence · Not medical advice
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