Comparison · NCT00936936-sae
Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT vs Cohort 2: HD GeM-DMC+ ICE for Refractory GCT: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT vs Cohort 2: HD GeM-DMC+ ICE for Refractory GCT: serious adverse events. Trial comparisons, record NCT00936936-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00936936-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 | 0.171 | 0.0853 | 0.313 | wilson | |
| Risk in group 2 | 0.087 | 0.0242 | 0.268 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0838 | -0.116 | 0.239 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.96 | 0.444 | 8.68 | log | |
| Odds ratio, group 1 over group 2 | 2.16 | 0.41 | 11.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT than on Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 11.9 | 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 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)~You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg.~HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC~Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.~Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.~Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.~Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.~Stem Cell Transplant: Stem cell infusion on Day 0.~Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)~HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC~Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.~Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.~Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.~Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3~Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.~Stem Cell Transplant: Stem cell infusion on Day 0. | 7 | 41 | EG000 |
| Group 2 | Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)~HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC~Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.~Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.~Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.~Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.~Stem Cell Transplant: Stem cell infusion on Day 0.~Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)~HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC~Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.~Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.~Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.~Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3~Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.~Stem Cell Transplant: Stem cell infusion on Day 0. | 2 | 23 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 2 years
Source ClinicalTrials.gov
Trial
- Title
- High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors
- NCT number
- NCT00936936
- Phases
- PHASE2
- Conditions
- Testicular Cancer
- Interventions
- Gemcitabine, Docetaxel, Melphalan, Carboplatin, Mesna, Ifosfamide, Etoposide, Stem Cell Transplant
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2024-08-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00936936?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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