Comparison · NCT03063632-sae
Group I (Pembrolizumab, Interferon Gamma-1b) vs Group II (Pembrolizumab, Interferon Gamma-1b): 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. Group I (Pembrolizumab, Interferon Gamma-1b) vs Group II (Pembrolizumab, Interferon Gamma-1b): serious adverse events. Trial comparisons, record NCT03063632-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03063632-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 | 0.25 | 0.102 | 0.495 | wilson | |
| Risk in group 2 | 0.417 | 0.193 | 0.68 | wilson | |
| Risk difference, group 1 minus group 2 | -0.167 | -0.469 | 0.165 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.6 | 0.204 | 1.77 | log | |
| Odds ratio, group 1 over group 2 | 0.467 | 0.0931 | 2.34 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Group I (Pembrolizumab, Interferon Gamma-1b) than on Group II (Pembrolizumab, Interferon Gamma-1b) | 6 | 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 | Group I (Pembrolizumab, Interferon Gamma-1b) | Patients with Mycosis Fungoides and Sezary Syndrome receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.~Interferon Gamma-1b: Given SC~Laboratory Biomarker Analysis: Ancillary studies~Pembrolizumab: Given IV | 4 | 16 | EG000 |
| Group 2 | Group II (Pembrolizumab, Interferon Gamma-1b) | Patients with advanced synovial sarcoma receive pembrolizumab IV over 30 minutes on day 1 of each cycle, and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.~Interferon Gamma-1b: Given SC~Laboratory Biomarker Analysis: Ancillary studies~Pembrolizumab: Given IV | 5 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
Source ClinicalTrials.gov
Trial
- Title
- Testing the Combination of Two Experimental Drugs MK-3475 (Pembrolizumab) and Interferon-gamma for the Treatment of Mycosis Fungoides and Sézary Syndrome and Advanced Synovial Sarcoma
- NCT number
- NCT03063632
- Phases
- PHASE2
- Conditions
Metastatic Myxoid Liposarcoma, Metastatic Round Cell Liposarcoma, Metastatic Synovial Sarcoma, Recurrent Mycosis Fungoides and Sezary Syndrome, Refractory Mycosis Fungoides and Sezary Syndrome, Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage II Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage III Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IIIA Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IIIB Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IVA Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage IVB Mycosis Fungoides and Sezary Syndrome AJCC v7, Unresectable Synovial Sarcoma
- Interventions
- Interferon Gamma-1b, Laboratory Biomarker Analysis, Pembrolizumab
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2022-08-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03063632?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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