Comparison · NCT00061945-sae
Phase I - Alemtuzumab and Combination Chemotherapy vs Phase II - Alemtuzumab and Combination Chemotherapy: 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. Phase I - Alemtuzumab and Combination Chemotherapy vs Phase II - Alemtuzumab and Combination Chemotherapy: serious adverse events. Trial comparisons, record NCT00061945-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00061945-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 | 0.504 | 0.416 | 0.592 | wilson | |
| Risk in group 2 | 0.541 | 0.469 | 0.612 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0372 | -0.151 | 0.0771 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.931 | 0.745 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 0.861 | 0.542 | 1.37 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Phase I - Alemtuzumab and Combination Chemotherapy than on Phase II - Alemtuzumab and Combination Chemotherapy | 26.9 | 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 | Phase I - Alemtuzumab and Combination Chemotherapy | See detailed description or participant flow. | 60 | 119 | EG000 |
| Group 2 | Phase II - Alemtuzumab and Combination Chemotherapy | See detailed description or participant flow. | 98 | 181 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
- NCT number
- NCT00061945
- Phases
- PHASE1, PHASE2
- Conditions
Acute Undifferentiated Leukemia, B-cell Adult Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, L1 Adult Acute Lymphoblastic Leukemia, L1 Childhood Acute Lymphoblastic Leukemia, L2 Adult Acute Lymphoblastic Leukemia, L2 Childhood Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive Childhood Precursor Acute Lymphoblastic Leukemia, T-cell Adult Acute Lymphoblastic Leukemia, T-cell Childhood Acute Lymphoblastic Leukemia, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia
- Interventions
allopurinol, cyclophosphamide, daunorubicin hydrochloride, vincristine sulfate, dexamethasone, asparaginase, filgrastim, imatinib mesylate, methotrexate, cytarabine, trimethoprim-sulfamethoxazole, mercaptopurine, leucovorin calcium, alemtuzumab, acyclovir, laboratory biomarker analysis, pharmacological study
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2014-04-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00061945?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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