Comparison · NCT00738582-sae
Amatuximab/Pemetrexed/Cisplatin vs Amatuximab: serious adverse events
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. Amatuximab/Pemetrexed/Cisplatin vs Amatuximab: serious adverse events. Trial comparisons, record NCT00738582-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00738582-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 | 0.427 | 0.329 | 0.531 | wilson | |
| Risk in group 2 | 0.268 | 0.17 | 0.396 | wilson | |
| Risk difference, group 1 minus group 2 | 0.159 | -0.00195 | 0.302 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.59 | 0.971 | 2.62 | log | |
| Odds ratio, group 1 over group 2 | 2.04 | 0.986 | 4.21 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Amatuximab/Pemetrexed/Cisplatin than on Amatuximab | 6.28 | 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 | Amatuximab/Pemetrexed/Cisplatin | Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy (Cycle length is 21 days). | 38 | 89 | EG000 |
| Group 2 | Amatuximab | Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]). | 15 | 56 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
Source ClinicalTrials.gov
Trial
- Title
- An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
- NCT number
- NCT00738582
- Phases
- PHASE2
- Conditions
- Malignant Pleural Mesothelioma
- Interventions
- MORAb-009 (Amatuximab), Pemetrexed, Cisplatin
- Lead sponsor
- Morphotek
- Results first posted
- 2022-09-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00738582?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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