Comparison · NCT02288897-sae
PV-10 vs Chemotherapy or Oncolytic Viral Therapy: 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. PV-10 vs Chemotherapy or Oncolytic Viral Therapy: serious adverse events. Trial comparisons, record NCT02288897-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02288897-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 | 0.0000000000000000139 | 0.215 | wilson | |
| Risk in group 2 | 0.125 | 0.0224 | 0.471 | wilson | |
| Risk difference, group 1 minus group 2 | -0.125 | -0.471 | 0.113 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on PV-10 than on Chemotherapy or Oncolytic Viral Therapy | 8 | from the risk difference interval | the interval includes no difference |
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 | PV-10 | Subjects received intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at 28-day intervals until complete response, disease progression or study termination.~PV-10 (10% rose bengal disodium)~PV-10 safety population includes two subjects who received PV-10 upon crossover after progression on comparator | 0 | 14 | EG000 |
| Group 2 | Chemotherapy or Oncolytic Viral Therapy | Subjects received (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination.~Dacarbazine, temozolomide or talimogene laherparepvec | 1 | 8 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All adverse events occurring between signing the informed consent form and 28 days following final administration of study drug, or that occurred at any time that might be at least possibly related to study drug, were followed until: 1. the event resolved; 2. the subject was lost to follow-up; 3. the event was otherwise explained; or 4. no further improvement or worsening was expected. Median duration of treatment was 11.8 and 9.5 weeks in each treatment group, respectively.
Source ClinicalTrials.gov
Trial
- Title
- PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
- NCT number
- NCT02288897
- Phases
- PHASE3
- Conditions
- Cutaneous Melanoma
- Interventions
- PV-10 (10% rose bengal disodium), Dacarbazine, temozolomide or talimogene laherparepvec
- Lead sponsor
- Provectus Biopharmaceuticals, Inc.
- Results first posted
- 2022-01-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02288897?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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