Comparison · NCT05093322-e7c6dca6
Dose Level 1 vs Dose Level 2: Number of Patients With Clinically Significant Vital Signs Abnormalities
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. Dose Level 1 vs Dose Level 2: Number of Patients With Clinically Significant Vital Signs Abnormalities. Trial comparisons, record NCT05093322-e7c6dca6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05093322-e7c6dca6
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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 | 0 | 0.278 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000555 | 0.561 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.561 | 0.278 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | 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 | Dose Level 1 | Patients received surufatinib 120 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first. | 0 | 10 | OG000 |
| Group 2 | Dose Level 2 | Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first. | 0 | 3 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Patients With Clinically Significant Vital Signs Abnormalities
- Description
- Vital signs included systolic blood pressure (BP), diastolic BP, heart rate, height, weight, respiratory rate, and body temperature.
- Time frame
- From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks
- Population
- The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors
- NCT number
- NCT05093322
- Phases
- PHASE1, PHASE2
- Conditions
- Solid Tumor, Lymphoma, Osteosarcoma, Ewing Sarcoma, Rhabdomyosarcoma, Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
- Interventions
- Surufatinib in combination with Gemcitabine
- Lead sponsor
- Hutchmed
- Results first posted
- 2024-05-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05093322?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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