Comparison · NCT02545907-sae
Dose Level 0 - Safety Population vs Dose Level 1 - Safety Population: 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. Dose Level 0 - Safety Population vs Dose Level 1 - Safety Population: serious adverse events. Trial comparisons, record NCT02545907-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02545907-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 | 0.333 | 0.0615 | 0.792 | wilson | |
| Risk in group 2 | 0.286 | 0.0822 | 0.641 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0476 | -0.4 | 0.55 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.161 | 8.48 | log | |
| Odds ratio, group 1 over group 2 | 1.25 | 0.0683 | 22.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Dose Level 0 - Safety Population than on Dose Level 1 - Safety Population | 21 | 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 | Dose Level 0 - Safety Population | All patients allocated to dose level 0 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set. | 1 | 3 | EG000 |
| Group 2 | Dose Level 1 - Safety Population | All patients allocated to dose level 1 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set. | 2 | 7 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All adverse events that occur between informed consent and 30 days post last trial treatment administration must be recorded in the patient notes and the trial CRFs, up to 7 months.
Source ClinicalTrials.gov
Trial
- Title
- A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis
- NCT number
- NCT02545907
- Phases
- PHASE1, PHASE2
- Conditions
- Amyloidosis
- Interventions
- Carfilzomib, Thalidomide, Dexamethasone
- Lead sponsor
- University College, London
- Results first posted
- 2021-04-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02545907?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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