Comparison · NCT01124734-sae
Course 1 Cycle 1 vs Course 1 Cycle 2: serious adverse events
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. Course 1 Cycle 1 vs Course 1 Cycle 2: serious adverse events. Trial comparisons, record NCT01124734-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01124734-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 | 0.0588 | 0.0105 | 0.27 | wilson | |
| Risk in group 2 | 0.0588 | 0.0105 | 0.27 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.216 | 0.216 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.0679 | 14.7 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.0574 | 17.4 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Course 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 | 1 | 17 | EG000 |
| Group 2 | Course 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. | 1 | 17 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- 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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01124734?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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