Comparison · NCT03088813-d81fe0e2
Part 1: Irinotecan Liposome Injection 85 mg/m^2 vs Part 1: Irinotecan Liposome Injection 70 mg/m^2: Part 1: Number of Participants With Dose-Limiting Toxicities (DLT)
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. Part 1: Irinotecan Liposome Injection 85 mg/m^2 vs Part 1: Irinotecan Liposome Injection 70 mg/m^2: Part 1: Number of Participants With Dose-Limiting Toxicities (DLT). Trial comparisons, record NCT03088813-d81fe0e2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03088813-d81fe0e2
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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 | 0.8 | 0.376 | 0.964 | wilson | |
| Risk in group 2 | 0.08 | 0.0222 | 0.25 | wilson | |
| Risk difference, group 1 minus group 2 | 0.72 | 0.263 | 0.894 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 10 | 2.47 | 40.5 | log | |
| Odds ratio, group 1 over group 2 | 46 | 3.33 | 635 | log | |
| Number needed to treat, for one more participant with the outcome on Part 1: Irinotecan Liposome Injection 85 mg/m^2 than on Part 1: Irinotecan Liposome Injection 70 mg/m^2 | 1.39 | 1.12 | 3.8 | from the risk difference interval |
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 | Part 1: Irinotecan Liposome Injection 85 mg/m^2 | Participants received irinotecan liposome injection 85 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent. | 4 | 5 | OG000 |
| Group 2 | Part 1: Irinotecan Liposome Injection 70 mg/m^2 | Participants received irinotecan liposome injection 70 mg/m\^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent. | 2 | 25 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Part 1: Number of Participants With Dose-Limiting Toxicities (DLT)
- Description
A TEAE was considered as DLT if it occurred during the safety evaluation period (i.e. first 28 days of treatment or 14 days after the second dose of study treatment if there was a treatment delay due to non-DLT related reasons) and were deemed related to the study treatment by the investigator. The determination of whether an Adverse Event was considered a Dose Limiting Toxicity was made by the Safety Review Committee (SRC) comprising the Part 1 Investigators and the Medical Monitor(s) of the Sponsor.
- Time frame
- From the start of the first study treatment administration (Day 1) up to 14 days after the second dose of study treatment administration, a maximum of 42 days
- Population
- Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection.
Source ClinicalTrials.gov
Trial
- Title
- Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer
- NCT number
- NCT03088813
- Phases
- PHASE3
- Conditions
- Small Cell Lung Cancer
- Interventions
- Irinotecan liposome injection, Topotecan
- Lead sponsor
- Ipsen
- Results first posted
- 2023-10-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03088813?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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