Comparison · NCT02003924-b0098dcb
Enzalutamide 160 mg vs Placebo: Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)
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. Enzalutamide 160 mg vs Placebo: Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs). Trial comparisons, record NCT02003924-b0098dcb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02003924-b0098dcb
On this page
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 | 0.0935 | 0.0765 | 0.114 | wilson | |
| Risk in group 2 | 0.0602 | 0.042 | 0.0857 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0333 | 0.0027 | 0.0607 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.55 | 1.03 | 2.34 | log | |
| Odds ratio, group 1 over group 2 | 1.61 | 1.04 | 2.5 | log | |
| Number needed to treat, for one more participant with the outcome on Enzalutamide 160 mg than on Placebo | 30 | 16.5 | 371 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Enzalutamide 160 mg | Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date. | 87 | 930 | OG000 |
| Group 2 | Placebo | Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date. | 28 | 465 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)
- Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious adverse events (AEs) and SAEs.
- Time frame
From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
- Population
The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
- NCT number
- NCT02003924
- Phases
- PHASE3
- Conditions
- Nonmetastatic Castration-Resistant Prostate Cancer, Prostate Cancer, Cancer of the Prostate
- Interventions
- Enzalutamide, Placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2018-07-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02003924?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02003924-b0098dcb