Comparison · NCT03519412-sae
MMR-proficient (MMRp) vs MMR-deficient (MMRd)/TMZ-primed TMB-high MMR-proficient (MMRp): 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. MMR-proficient (MMRp) vs MMR-deficient (MMRd)/TMZ-primed TMB-high MMR-proficient (MMRp): serious adverse events. Trial comparisons, record NCT03519412-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03519412-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 | 0.212 | 0.131 | 0.325 | wilson | |
| Risk in group 2 | 0.351 | 0.24 | 0.481 | wilson | |
| Risk difference, group 1 minus group 2 | -0.139 | -0.292 | 0.0196 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.605 | 0.337 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 0.498 | 0.223 | 1.11 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on MMR-proficient (MMRp) than on MMR-deficient (MMRd)/TMZ-primed TMB-high MMR-proficient (MMRp) | 7.21 | 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 | MMR-proficient (MMRp) | MGMT-IHC-negative, MGMT promoter methylation-positive patient population treated with temozolomide (induction) until disease progression or unacceptable toxicity, whichever comes first. | 14 | 66 | EG000 |
| Group 2 | MMR-deficient (MMRd)/TMZ-primed TMB-high MMR-proficient (MMRp) | MMRd and TMB-high TMZ-primed MMRp patients treated with pembrolizumab until tumor progression or discontinuation for toxicity. | 20 | 57 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-Cause Mortality monitored/assessed up to 72 months. Adverse Events monitored/assessed from the time the first dose of study medication (either pembrolizumab or temozolomide) is administered until 30 days following discontinuation of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Pembrolizumab in MMR-Proficient Metastatic Colorectal Cancer Pharmacologically Primed to Trigger Hypermutation Status
- NCT number
- NCT03519412
- Phases
- PHASE2
- Conditions
- Colorectal Neoplasms, Microsatellite Instability
- Interventions
- temozolomide (induction),, pembrolizumab (treatment)
- Lead sponsor
- IFOM ETS - The AIRC Institute of Molecular Oncology
- Results first posted
- 2026-03-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03519412?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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