Comparison · NCT00516503-sae
Baclofen-amitriptyline Hydrochloride-ketamine vs Placebo: 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. Baclofen-amitriptyline Hydrochloride-ketamine vs Placebo: serious adverse events. Trial comparisons, record NCT00516503-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00516503-sae
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 | 0.0099 | 0.00175 | 0.054 | wilson | |
| Risk in group 2 | 0.0098 | 0.00173 | 0.0535 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0000971 | -0.0443 | 0.0449 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.064 | 15.9 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.0623 | 16.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Baclofen-amitriptyline Hydrochloride-ketamine than on Placebo | 10,300 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Baclofen-amitriptyline Hydrochloride-ketamine | Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically. | 1 | 101 | EG000 |
| Group 2 | Placebo | Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically | 1 | 102 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
- NCT number
- NCT00516503
- Phases
- PHASE3
- Conditions
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Neurotoxicity, Pain, Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- baclofen/amitriptyline/ketamine gel, placebo
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Results first posted
- 2017-08-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00516503?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/NCT00516503-sae