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Comparison · NCT01124734-deaths

Course 1 Cycle 1 vs Course 1 Cycle 2: deaths from any cause

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. Course 1 Cycle 1 vs Course 1 Cycle 2: deaths from any cause. Trial comparisons, record NCT01124734-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01124734-deaths

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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 1000.184wilson
Risk in group 20.5290.310.738wilson
Risk difference, group 1 minus group 2-0.529-0.738-0.243newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treat, for one fewer death from any cause on Course 1 Cycle 1 than on Course 1 Cycle 21.891.354.12from 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 1Course 1 Cycle 1
This study is a single arm study. All participants received the same treatment regimen.~Participants were given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals.~Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg
017EG000
Group 2Course 1 Cycle 2
Patients will be given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. On the day after discharge, patients will be given oral temozolomide at 75 mg/m2 daily for 21 days.~Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg~Temozolomide: Patients would receive temozolomide at 75 mg/m2 after discharge from receipt of the second cycle of high dose IL-2. Patients would take the medication at bedtime daily. Four weeks after cycle 2 of a course, they would take it for 21 days.
917EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.

Source ClinicalTrials.gov

Trial

Title
High Dose Interleukin-2 Followed by Intermittent Low Dose Temozolomide in Patients With Melanoma
NCT number
NCT01124734
Phases
PHASE2
Conditions
Malignant Melanoma
Interventions
Interleukin-2, Temozolomide
Lead sponsor
Milton S. Hershey Medical Center
Results first posted
2019-02-12

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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