Comparison · NCT02756845-sae
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years vs Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years: 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. Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years vs Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years: serious adverse events. Trial comparisons, record NCT02756845-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02756845-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 | 0.385 | 0.177 | 0.645 | wilson | |
| Risk in group 2 | 0.5 | 0.0945 | 0.905 | wilson | |
| Risk difference, group 1 minus group 2 | -0.115 | -0.571 | 0.366 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.769 | 0.164 | 3.61 | log | |
| Odds ratio, group 1 over group 2 | 0.625 | 0.0315 | 12.4 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years than on Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | 8.67 | 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 | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | Participants aged 12 to ≤ 21 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance. | 5 | 13 | EG000 |
| Group 2 | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | Participants aged 2 to \< 12 years were administered an initial dose of talimogene laherparepvec at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (± 3) later. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL were administered every 14 (± 3) days for up to approximately 9 months. Talimogene laherparepvec was administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance. | 1 | 2 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1
Source ClinicalTrials.gov
Trial
- Title
- Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors
- NCT number
- NCT02756845
- Phases
- PHASE1
- Conditions
- Advanced Non CNS Tumors
- Interventions
- Talimogene Laherparepvec
- Lead sponsor
- Amgen
- Results first posted
- 2024-02-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02756845?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.
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GET https://conductscience.org/api/comparisons/v1/NCT02756845-sae