Comparison · NCT01535053-sae
Regimen I (Dactinomycin) vs Regimen II (Methotrexate): 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. Regimen I (Dactinomycin) vs Regimen II (Methotrexate): serious adverse events. Trial comparisons, record NCT01535053-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01535053-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 | 0.0357 | 0.00633 | 0.177 | wilson | |
| Risk in group 2 | 0.0385 | 0.00682 | 0.189 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00275 | -0.156 | 0.142 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.929 | 0.0612 | 14.1 | log | |
| Odds ratio, group 1 over group 2 | 0.926 | 0.0549 | 15.6 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Regimen I (Dactinomycin) than on Regimen II (Methotrexate) | 364 | 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 | Regimen I (Dactinomycin) | IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose) | 1 | 28 | EG000 |
| Group 2 | Regimen II (Methotrexate) | institutional preference of either:~* IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR~* IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days. | 1 | 26 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Through Study Treatment and up to 30 days after discontinuing treatment.
Source ClinicalTrials.gov
Trial
- Title
- Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia
- NCT number
- NCT01535053
- Phases
- PHASE3
- Conditions
- Choriocarcinoma, FIGO Stage I Gestational Trophoblastic Tumor, FIGO Stage II Gestational Trophoblastic Tumor, FIGO Stage III Gestational Trophoblastic Tumor, Hydatidiform Mole
- Interventions
- Dactinomycin, Leucovorin Calcium, Methotrexate, Quality-of-Life Assessment
- Lead sponsor
- GOG Foundation
- Results first posted
- 2019-08-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01535053?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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