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Comparison · NCT02545907-1ae45095

Dose Level 0- Safety Population vs Dose Level 1- Safety Population: Number of Patients Progression-free at 6 Months Based on Reported Data.

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. Dose Level 0- Safety Population vs Dose Level 1- Safety Population: Number of Patients Progression-free at 6 Months Based on Reported Data. Trial comparisons, record NCT02545907-1ae45095. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02545907-1ae45095

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 110.4391wilson
Risk in group 210.6461wilson
Risk difference, group 1 minus group 20-0.5610.354newcombe hybrid score
Risk ratio, group 1 over group 2111log
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treatfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Dose Level 0- Safety PopulationAll 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.33OG000
Group 2Dose Level 1- Safety PopulationAll 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.77OG001

Outcome

Type
SECONDARY
Title
Number of Patients Progression-free at 6 Months Based on Reported Data.
Description
The number of patients who are progression-free at 6 months will be assessed based on reported data. Patients who are progression-free will have not had an haematological relapse or organ progression.~Haematological relapse is defined as:~From CR: Increase in the aberrant serum free light chain concentration to outside the normal range and by a factor of ≥2 from that at the time of CR or re-appearance of the original paraprotein~From PR or VGPR: Increase in the aberrant free light chain concentration by a factor of ≥2 from that at the time of PR (≥50% change in ratio away from normal in patients with renal failure) or doubling of the serum paraprotein level (if starting \>5g/L) or doubling and increase of serum paraprotein to \>5g/L (if starting \<5g/L)~Organ progression is defined, by organ, as:~Heart: Interventricular septal thickness increased by \>2 mm compared with baseline or 20% decline in ejection fraction~Kidney: 50% increase (at least 1 g/day) in 24-hr urinary
Time frame
6 months
Population

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

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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