Comparison · NCT01998035-sae
Phase 1 vs Phase 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. Phase 1 vs Phase 2: serious adverse events. Trial comparisons, record NCT01998035-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01998035-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 | 0.423 | 0.255 | 0.611 | wilson | |
| Risk in group 2 | 0.48 | 0.3 | 0.665 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0569 | -0.307 | 0.203 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.881 | 0.481 | 1.62 | log | |
| Odds ratio, group 1 over group 2 | 0.794 | 0.263 | 2.4 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Phase 1 than on Phase 2 | 17.6 | 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 1 | Phase 1 is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. Patients will be administered the study drugs in a 3 + 3 dose-escalation study.~Romidepsin is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. Romidepsin is classified as a Histone Deacetylase Inhibitor. Dose escalation: 10, 14 mg/m2~Oral 5-Azacitidine is a pyrimidine nucleoside analogue of cytidine with antineoplastic activity. Dose escalation: 100, 200, 300 mg | 11 | 26 | EG000 |
| Group 2 | Phase 2 | Patients will be treated with oral 5-azacytidine and romidepsin at the MTD. The treatment will be administered as follows: oral 5-azacytidine 300 mg (flat dose) on Days 1-14 and romidepsin 14 mg/m2 (flat dose) on Days 8, 15, and 22 on a 35-day cycle. | 12 | 25 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 1.5 years
Source ClinicalTrials.gov
Trial
- Title
- Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies
- NCT number
- NCT01998035
- Phases
- PHASE1, PHASE2
- Conditions
- Lymphoid Malignancies, Lymphoma, Hodgkin Lymphoma, Non-hodgkin Lymphoma
- Interventions
- RomiDEPsin 10 MG/M2, Oral 5-Azacitidine 100 MG, Romidepsin 14 MG/M2, Oral 5-Azacitidine 200 MG, Oral 5-Azacitidine 300 MG
- Lead sponsor
- Columbia University
- Results first posted
- 2024-08-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01998035?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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