Comparison · NCT01875250-fd97f32d
Arm A - Enzalutamide for 3 Months vs Arm B - Enzalutamide for 3 Months + PSA-TRICOM: Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Arm A - Enzalutamide for 3 Months vs Arm B - Enzalutamide for 3 Months + PSA-TRICOM: Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Trial comparisons, record NCT01875250-fd97f32d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01875250-fd97f32d
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 1 | 0.832 | 1 | wilson | |
| Risk in group 2 | 1 | 0.832 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.168 | 0.168 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm A - Enzalutamide for 3 Months | Enzalutamide for 3 months~Enzalutamide (Xtandi): An androgen receptor inhibitor. | 19 | 19 | OG000 |
| Group 2 | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21~PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.~PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.~Enzalutamide (Xtandi): An androgen receptor inhibitor. | 19 | 19 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
- Description
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
- Time frame
- Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
- Population
Source ClinicalTrials.gov
Trial
- Title
- Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer
- NCT number
- NCT01875250
- Phases
- PHASE2
- Conditions
- Prostate Cancer
- Interventions
- PROSTVAC-F (Fowlpox)/TRICOM, PROSTVAC-V (Vaccinia)/TRICOM, Enzalutamide (Xtandi)
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2020-09-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01875250?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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