Comparison · NCT01574716-78300b5c
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel vs Part 2: Placebo + Gemcitabine/Docetaxel: Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels
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 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel vs Part 2: Placebo + Gemcitabine/Docetaxel: Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels. Trial comparisons, record NCT01574716-78300b5c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01574716-78300b5c
On this page
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 | 0.0269 | wilson | |
| Risk in group 2 | 0 | 0 | 0.052 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.052 | 0.0269 | 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 | Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel | Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | 0 | 139 | OG000 |
| Group 2 | Part 2: Placebo + Gemcitabine/Docetaxel | Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m\^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m\^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle. | 0 | 70 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels
- Description
- Time frame
- Up to approximately 3 years
- Population
- The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.
Source ClinicalTrials.gov
Trial
- Title
- Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation
- NCT number
- NCT01574716
- Phases
- PHASE2
- Conditions
- Metastatic Soft Tissue Sarcoma
- Interventions
- MORAb-004, Gemcitabine, Docetaxel, Gemcitabine, Docetaxel, Placebo
- Lead sponsor
- Morphotek
- Results first posted
- 2019-08-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01574716?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01574716-78300b5c