Comparison · NCT01335009-sae
MORAb-004 2 mg/kg vs MORAb-004 4 mg/kg: 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. MORAb-004 2 mg/kg vs MORAb-004 4 mg/kg: serious adverse events. Trial comparisons, record NCT01335009-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01335009-sae
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 | 0.425 | 0.285 | 0.578 | wilson | |
| Risk in group 2 | 0.444 | 0.295 | 0.604 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0194 | -0.232 | 0.194 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.956 | 0.572 | 1.6 | log | |
| Odds ratio, group 1 over group 2 | 0.924 | 0.373 | 2.29 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on MORAb-004 2 mg/kg than on MORAb-004 4 mg/kg | 51.4 | 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 2 mg/kg | Participants received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. | 17 | 40 | EG000 |
| Group 2 | MORAb-004 4 mg/kg | Participants received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Participants who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Participants were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment. | 16 | 36 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the first dose of study drug to 45 days after the last dose of study drug (up to approximately 8 years 11 months)
Source ClinicalTrials.gov
Trial
- Title
- Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma
- NCT number
- NCT01335009
- Phases
- PHASE2
- Conditions
- Metastatic Melanoma
- Interventions
- MORAb-004 (monoclonal antibody)
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2021-09-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01335009?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/NCT01335009-sae