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Comparison · NCT00003910-sae

Methotrexate vs Cyclophosphamide: 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. Methotrexate vs Cyclophosphamide: serious adverse events. Trial comparisons, record NCT00003910-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00003910-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.9490.8610.983wilson
Risk in group 20.50.280.72wilson
Risk difference, group 1 minus group 20.4490.2120.672newcombe hybrid score
Risk ratio, group 1 over group 21.91.163.11log
Odds ratio, group 1 over group 218.74.0885.3log
Number needed to harm, for one more participant with a serious adverse event on Methotrexate than on Cyclophosphamide2.231.494.72from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Methotrexate
MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
5659EG000
Group 2Cyclophosphamidestep 2 patients who received CY816EG001

Harm

What it counts
Total, serious adverse events
Time frame
Assessed every 30 days while on treatment and for 30 days after the end of treatment.

Source ClinicalTrials.gov

Trial

Title
Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia
NCT number
NCT00003910
Phases
PHASE2
Conditions
Leukemia
Interventions
Cyclophosphamide, Methotrexate, Prednisone
Lead sponsor
Eastern Cooperative Oncology Group
Results first posted
2013-05-27

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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