Comparison · NCT02564198-5ffaccec
8 mg/kg Ramucirumab (Part A) vs 12 mg/kg Ramucirumab (Part A): Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab
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. 8 mg/kg Ramucirumab (Part A) vs 12 mg/kg Ramucirumab (Part A): Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab. Trial comparisons, record NCT02564198-5ffaccec. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02564198-5ffaccec
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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 | 0.125 | 0.0224 | 0.471 | wilson | |
| Risk in group 2 | 0.0667 | 0.0119 | 0.298 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0583 | -0.195 | 0.409 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.88 | 0.134 | 26.2 | log | |
| Odds ratio, group 1 over group 2 | 2 | 0.108 | 37 | log | |
| Number needed to treat, for one more participant with the outcome on 8 mg/kg Ramucirumab (Part A) than on 12 mg/kg Ramucirumab (Part A) | 17.1 | 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 | 8 mg/kg Ramucirumab (Part A) | Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion Q2W with 3 doses per 42 day cycle. | 1 | 8 | OG000 |
| Group 2 | 12 mg/kg Ramucirumab (Part A) | Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle. | 1 | 15 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab
- Description
A DLT is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0:~1\. Any death not clearly due to the underlying disease or extraneous causes 2. Neutropenic fever 2. Any Grade ≥3 non-hematologic toxicity 3. Grade ≥4 neutropenia or thrombocytopenia \>7 days 4. Grade ≥3 thrombocytopenia with bleeding 5. Grade ≥3 nausea/vomiting or diarrhea\>72 hours with adequate antiemetic and other supportive care 6. Grade ≥3 fatigue ≥1 week 7. Grade ≥3 electrolyte abnormality that lasts\>72 hours, unless the Participant has clinical symptoms, in which case all Grade 3+electrolyte abnormality regardless of duration should count as a DLT.~8\. Grade ≥3 prolongation of QT interval corrected using the Fridericia formula on 2 separate electrocardiogram readings approximately 5 min apart.
- Time frame
- Baseline to Study Completion (Up to 42 Months)
- Population
- All randomized participants from Part A, who received at least one dose of study drug.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors
- NCT number
- NCT02564198
- Phases
- PHASE1
- Conditions
- Pediatric Solid Tumor, Refractory Tumor, Recurrent Tumor, CNS Malignancies
- Interventions
- Ramucirumab
- Lead sponsor
- Eli Lilly and Company
- Results first posted
- 2021-08-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02564198?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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