Comparison · NCT03405792-sae
Optune System Combined With Temozolomide (TMZ) + Pembrolizumab vs Historical Control Optune System Combined With Temozolomide (TMZ): 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. Optune System Combined With Temozolomide (TMZ) + Pembrolizumab vs Historical Control Optune System Combined With Temozolomide (TMZ): serious adverse events. Trial comparisons, record NCT03405792-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03405792-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 | 0.643 | 0.458 | 0.793 | wilson | |
| Risk in group 2 | 0 | 0 | 0.00835 | wilson | |
| Risk difference, group 1 minus group 2 | 0.643 | 0.458 | 0.793 | 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 harm, for one more participant with a serious adverse event on Optune System Combined With Temozolomide (TMZ) + Pembrolizumab than on Historical Control Optune System Combined With Temozolomide (TMZ) | 1.56 | 1.26 | 2.18 | from the risk difference interval |
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 | Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | Patients with newly-diagnosed GBM who undergo maximal safe resection (biopsy alone is eligible) followed by chemoradiation consisting of concomitant TMZ daily and radiation therapy (RT) with minimal RT will be eligible for this trial. Four to six weeks after finishing chemoradiation, patients will start monthly cycles of adjuvant TMZ. Treatment with Optune will start at approximately the same time as the first cycle of adjuvant TMZ and continue until second disease progression or a maximum of 2 years. Within one week after starting Cycle 2 of adjuvant TMZ and Optune therapy, patients will begin open-label treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first.~Temozolomide (TMZ): Patients will begin treatment with adjuvant TMZ at least 4 weeks but no more than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and maximum of 12 cycles of adjuvant TMZ will be given depending on tolerability and toxicity.~Optune System: Patients will undergo 24-months of planned treatment with Optune therapy.~Pembrolizumab: Pembrolizumab will be given intravenously every 3 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. Treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first. | 18 | 28 | EG000 |
| Group 2 | Historical Control Optune System Combined With Temozolomide (TMZ) | Historical control of patients treated with Optune System combined with Temozolomide alone from the EF-14 study based on data published by Stupp et al, 2017. | 0 | 456 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab.
Source ClinicalTrials.gov
Trial
- Title
- Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP)
- NCT number
- NCT03405792
- Phases
- PHASE2
- Conditions
- Glioblastoma, Glioblastoma, WHO Grade IV
- Interventions
- Temozolomide (TMZ), Optune System, Pembrolizumab
- Lead sponsor
- University of Florida
- Results first posted
- 2024-04-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03405792?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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