Comparison · NCT01607879-sae
Standard of Care ADT + (HMB + AG) vs Standard of Care ADT: serious adverse events
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. Standard of Care ADT + (HMB + AG) vs Standard of Care ADT: serious adverse events. Trial comparisons, record NCT01607879-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01607879-sae
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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 | 0.0417 | 0.00739 | 0.202 | wilson | |
| Risk in group 2 | 0.0833 | 0.0232 | 0.258 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0417 | -0.22 | 0.13 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.5 | 0.0485 | 5.15 | log | |
| Odds ratio, group 1 over group 2 | 0.478 | 0.0404 | 5.66 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Standard of Care ADT + (HMB + AG) than on Standard of Care ADT | 24 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Standard of Care ADT + (HMB + AG) | Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)~Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.~Take one packet twice daily for 3 months | 1 | 24 | EG000 |
| Group 2 | Standard of Care ADT | Standard of care androgen deprivation therapy~Standard of care ADT: Patient will receive standard of care androgen deprivation therapy (ADT) alone | 2 | 24 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 8 months
Source ClinicalTrials.gov
Trial
- Title
- Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation
- NCT number
- NCT01607879
- Phases
- PHASE2
- Conditions
- Prostate Cancer
- Interventions
- Standard of care ADT + (HMB + arginine + glutamine), Standard of care ADT
- Lead sponsor
- Medical College of Wisconsin
- Results first posted
- 2023-09-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01607879?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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