Comparison · NCT00363649-f2495dfd
Arm A vs Arm B: Early Discontinuation
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. Arm A vs Arm B: Early Discontinuation. Trial comparisons, record NCT00363649-f2495dfd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00363649-f2495dfd
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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 | 0.333 | 0.192 | 0.512 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000139 | 0.133 | wilson | |
| Risk difference, group 1 minus group 2 | 0.333 | 0.139 | 0.512 | 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 treat, for one more participant with the outcome on Arm A than on Arm B | 3 | 1.95 | 7.18 | 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 | Arm A | Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.~Interferon alfa: Given by injection~Sargramostim: Given by injection | 10 | 30 | OG000 |
| Group 2 | Arm B | Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).~GM-K562 cell vaccine: Given by injection | 0 | 25 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Early Discontinuation
- Description
- Number of participants unable to complete protocol-specified treatment due to toxicity.
- Time frame
- 1 year
- Population
- This outcome includes all participants who were either started on an arm or crossed over to an arm.
Source ClinicalTrials.gov
Trial
- Title
- Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI
- NCT number
- NCT00363649
- Phases
- PHASE2
- Conditions
- Leukemia
- Interventions
- GM-K562 cell vaccine, Interferon alfa, Sargramostim
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Results first posted
- 2018-11-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00363649?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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