Trial · NCT05405166
Results by group2,170
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 2,170
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Isa-IV + Pd | 70.5 | 0.6467 to 0.7591 | percentage of participants | |
| Overall Response Rate (ORR) | Isa-SC + Pd | 71.1 | 0.6522 to 0.7651 | percentage of participants | |
| Observed Concentration Before Dosing (Ctrough) of Isatuximab at Steady State | Isa-IV + Pd | 340 | Standard Deviation 169 | microgram/milliliter (mcg/mL) | |
| Observed Concentration Before Dosing (Ctrough) of Isatuximab at Steady State | Isa-SC + Pd | 499 | Standard Deviation 259 | microgram/milliliter (mcg/mL) | |
| Very Good Partial Response or Better Rate | Isa-IV + Pd | 45.9 | percentage of participants | ||
| Very Good Partial Response or Better Rate | Isa-SC + Pd | 46.4 | percentage of participants | ||
| Ctrough of Isatuximab at 4 Weeks (CT4W) | Isa-IV + Pd | 302 | Standard Deviation 117 | mcg/mL | |
| Ctrough of Isatuximab at 4 Weeks (CT4W) | Isa-SC + Pd | 421 | Standard Deviation 215 | mcg/mL | |
| Percentage of Participants With Infusion Reactions | Isa-IV + Pd | 25.0 | 95% Confidence Interval 19.89 to 30.68 | percentage of participants | |
| Percentage of Participants With Infusion Reactions | Isa-SC + Pd | 1.5 | 95% Confidence Interval 0.42 to 3.85 | percentage of participants | |
Percentage of Participants Who Responded Very Satisfied and Satisfied to the 'Patient Experience and Satisfaction Questionnaire (PESQ-FU)': Satisfaction With Injection Method' (Item-8) at Cycle 5 Day 15 | Isa-IV + Pd | 53.4 | percentage of participants | ||
Percentage of Participants Who Responded Very Satisfied and Satisfied to the 'Patient Experience and Satisfaction Questionnaire (PESQ-FU)': Satisfaction With Injection Method' (Item-8) at Cycle 5 Day 15 | Isa-SC + Pd | 70.0 | percentage of participants | ||
| Duration of Response (DOR) | Isa-IV + Pd | NA | 95% Confidence Interval NA to NA | months | |
| Duration of Response (DOR) | Isa-SC + Pd | NA | 95% Confidence Interval 18.300 to NA | months | |
| Time to First Response (TT1R) | Isa-IV + Pd | 1.91 | 95% Confidence Interval 1.216 to 1.971 | months | |
| Time to First Response (TT1R) | Isa-SC + Pd | 2.04 | 95% Confidence Interval 1.906 to 2.793 | months | |
| Time to Best Response (TTBR) | Isa-IV + Pd | 3.94 | 95% Confidence Interval 3.548 to 4.862 | months | |
| Time to Best Response (TTBR) | Isa-SC + Pd | 4.60 | 95% Confidence Interval 3.811 to 5.125 | months | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Isa-IV + Pd | TEAEs | 255 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Isa-SC + Pd | TEAEs | 255 | Participants |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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