Comparison · NCT01507545-sae
MORAb-004 8.0 mg/kg + BSC vs Placebo + BSC: 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-004 8.0 mg/kg + BSC vs Placebo + BSC: serious adverse events. Trial comparisons, record NCT01507545-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01507545-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 | 0.378 | 0.281 | 0.486 | wilson | |
| Risk in group 2 | 0.375 | 0.242 | 0.53 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00305 | -0.18 | 0.174 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.619 | 1.64 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.464 | 2.21 | log | |
| Number needed to harm, for one more participant with a serious adverse event on MORAb-004 8.0 mg/kg + BSC than on Placebo + BSC | 328 | 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-004 8.0 mg/kg + BSC | Participants received MORAb-004 8 mg/kg, infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24). | 31 | 82 | EG000 |
| Group 2 | Placebo + BSC | Participants received MORAb-004 matching placebo infusion IV, once weekly, in each 2-week treatment cycle along with the BSC which included those measures intended to provide palliation of all symptoms and improve quality of life, until disease progression or discontinuation from any reason (up to Cycle 24). | 15 | 40 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the date of randomization of the study drug up to 45 days after the last infusion of study drug (approximately up to 1 year 7 months)
Source ClinicalTrials.gov
Trial
- Title
- Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
- NCT number
- NCT01507545
- Phases
- PHASE2
- Conditions
- Metastatic Colorectal Cancer, Colorectal Cancer
- Interventions
- MORAb-004, Placebo, Best supportive care
- Lead sponsor
- Morphotek
- Results first posted
- 2022-05-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01507545?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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