TriangleNCT03914612 · OUTCOME
Concordance Between Institutional Mismatch Repair (MMR) Immunohistochemistry (IHC) Testing and Centralized MMR IHC
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- agreement score
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- IHC testing values (for both central and institutional) were collected at baseline.
What was measured
Concordance between institutional MMR IHC testing and centralized MMR IHC. The concordance of institutional MMR IHC testing and centralized MMR IHC will be characterized by agreement statistics including the kappa statistic (e.g. Cohen's kappa coefficient).
Analysis population: Patients from Japan were excluded. Otherwise all patients with a valid institutional MMR IHC status and a valid centralized MMR IHC status at baseline.
Groups in this outcome
Arm I: Active Comparator (Placebo, Paclitaxel, Carboplatin)
COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
Arm II: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm I: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 375 |
| Arm II: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 377 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I: Active Comparator (Placebo, Paclitaxel, Carboplatin) | 0.9197 | Not reported | 0.875 | 0.9644 | Not reported |
| Arm II: Experimental (Pembrolizumab, Paclitaxel, Carboplatin) | 0.8944 | Not reported | 0.8438 | 0.945 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.875
- upper Limit
- 0.9644
- value
- 0.9197
- group Id
- OG001
- lower Limit
- 0.8438
- upper Limit
- 0.945
- value
- 0.8944
- denoms
- counts
- group Id
- OG000
- value
- 375
- group Id
- OG001
- value
- 377
- units
- Participants
- description
- Concordance between institutional MMR IHC testing and centralized MMR IHC. The concordance of institutional MMR IHC testing and centralized MMR IHC will be characterized by agreement statistics including the kappa statistic (e.g. Cohen's kappa coefficient).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm I: Active Comparator (Placebo, Paclitaxel, Carboplatin)
- description
- COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm II: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
- param Type
- NUMBER
- population Description
- Patients from Japan were excluded. Otherwise all patients with a valid institutional MMR IHC status and a valid centralized MMR IHC status at baseline.
- reporting Status
- POSTED
- time Frame
- IHC testing values (for both central and institutional) were collected at baseline.
- title
- Concordance Between Institutional Mismatch Repair (MMR) Immunohistochemistry (IHC) Testing and Centralized MMR IHC
- type
- SECONDARY
- unit Of Measure
- agreement score
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Preserved source evidence · Not medical advice