Comparison · NCT00570713-sae
MORAb-009 Plus Gemcitabine ('MORAb-009') vs Placebo Plus Gemcitabine ('Placebo'): serious adverse events
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. MORAb-009 Plus Gemcitabine ('MORAb-009') vs Placebo Plus Gemcitabine ('Placebo'): serious adverse events. Trial comparisons, record NCT00570713-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00570713-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 | 0.671 | 0.557 | 0.768 | wilson | |
| Risk in group 2 | 0.72 | 0.61 | 0.809 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0488 | -0.193 | 0.0981 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.932 | 0.753 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 0.794 | 0.394 | 1.6 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on MORAb-009 Plus Gemcitabine ('MORAb-009') than on Placebo Plus Gemcitabine ('Placebo') | 20.5 | 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 | MORAb-009 Plus Gemcitabine ('MORAb-009') | MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. | 49 | 73 | EG000 |
| Group 2 | Placebo Plus Gemcitabine ('Placebo') | Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. | 54 | 75 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Baseline up to 21 months.
Source ClinicalTrials.gov
Trial
- Title
- An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer
- NCT number
- NCT00570713
- Phases
- PHASE2
- Conditions
- Pancreatic Cancer
- Interventions
- MORAb-009, Placebo, Gemcitabine
- Lead sponsor
- Morphotek
- Results first posted
- 2012-03-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00570713?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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