Trial Outcomes & Findings for SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM (NCT NCT05405166)
NCT ID: NCT05405166
Last Updated: 2025-11-14
Results Overview
ORR by independent review committee (IRC) using 2016 international myeloma working group (IMWG) criteria:Percentage of participants with complete response (CR),stringent CR (sCR),very good partial response (VGPR) \& partial response (PR).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas (STP),\<5% plasma cells in bone marrow (BM) aspirates \& a normal free light chain(FLC)ratio (0.26-1.65).sCR:CR plus no clonal cells in BM biopsy. VGPR:serum \& urine M-protein detectable by immunofixation, not electrophoresis;\>=90% reduction in serum M-protein plus urine M-protein level\<100mg/24hour(h);\>=90% decrease in sum of maximal perpendicular diameter (SPD) compared to baseline in STP;FLC only:\>=90% decrease in difference between involved and uninvolved FLC levels.PR:\>=50% reduction of serum M-protein and reduction in 24h urine M-protein by \>=90% or to \<200mg/24h.In addition to above, if present at baseline,\>=50% reduction in size SPD of STPs also required.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
531 participants
Primary outcome timeframe
From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
Results posted on
2025-11-14
Participant Flow
This study was conducted at 120 sites in 21 countries. A total of 637 participants were screened from 23-Jun-2022 to 13-May-2024, of which 106 were screen failures. Screen failures were mainly due to not meeting eligibility criteria.
A total of 531 participants were randomized in a 1:1 ratio to receive isatuximab (Isa) either via intravenous (IV) or subcutaneous (SC) route in combination with pomalidomide and dexamethasone (Pd). Interim results are presented up to primary completion date (PCD) of 06-Nov-2024. Reasons for study discontinuation at PCD are presented. Each cycle=28 days.
Participant milestones
| Measure |
Isa-IV + Pd
Participants received isatuximab 10 milligrams/kilogram (mg/kg) IV infusion once weekly (QW) (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg every 2 weeks (Q2W) (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable adverse events (AEs), participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-SC + Pd
Participants received isatuximab 1400 mg SC injection administered via an on-body delivery system (OBDS) which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Overall Study
STARTED
|
268
|
263
|
|
Overall Study
Randomized and Treated
|
264
|
263
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
268
|
263
|
Reasons for withdrawal
| Measure |
Isa-IV + Pd
Participants received isatuximab 10 milligrams/kilogram (mg/kg) IV infusion once weekly (QW) (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg every 2 weeks (Q2W) (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable adverse events (AEs), participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-SC + Pd
Participants received isatuximab 1400 mg SC injection administered via an on-body delivery system (OBDS) which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Overall Study
Death
|
49
|
50
|
|
Overall Study
Withdrawal by Subject
|
10
|
3
|
|
Overall Study
Ongoing at the time of PCD
|
209
|
210
|
Baseline Characteristics
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
Baseline characteristics by cohort
| Measure |
Isa-IV + Pd
n=268 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-SC + Pd
n=263 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Total
n=531 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 9.7 • n=10 Participants
|
65.7 years
STANDARD_DEVIATION 9.4 • n=10 Participants
|
65.2 years
STANDARD_DEVIATION 9.6 • n=20 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=10 Participants
|
126 Participants
n=10 Participants
|
238 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=10 Participants
|
137 Participants
n=10 Participants
|
293 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
58 Participants
n=10 Participants
|
53 Participants
n=10 Participants
|
111 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
22 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
184 Participants
n=10 Participants
|
184 Participants
n=10 Participants
|
368 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=10 Participants
|
14 Participants
n=10 Participants
|
25 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 monthsPopulation: The intent-to-treat (ITT) population included all randomized population (all participants who had given their informed consent and for whom there was confirmation of successful allocation of a randomization number by the interactive response technology \[IRT\]). Percentages are rounded off to the tenth decimal place.
ORR by independent review committee (IRC) using 2016 international myeloma working group (IMWG) criteria:Percentage of participants with complete response (CR),stringent CR (sCR),very good partial response (VGPR) \& partial response (PR).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas (STP),\<5% plasma cells in bone marrow (BM) aspirates \& a normal free light chain(FLC)ratio (0.26-1.65).sCR:CR plus no clonal cells in BM biopsy. VGPR:serum \& urine M-protein detectable by immunofixation, not electrophoresis;\>=90% reduction in serum M-protein plus urine M-protein level\<100mg/24hour(h);\>=90% decrease in sum of maximal perpendicular diameter (SPD) compared to baseline in STP;FLC only:\>=90% decrease in difference between involved and uninvolved FLC levels.PR:\>=50% reduction of serum M-protein and reduction in 24h urine M-protein by \>=90% or to \<200mg/24h.In addition to above, if present at baseline,\>=50% reduction in size SPD of STPs also required.
Outcome measures
| Measure |
Isa-SC + Pd
n=263 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=268 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
71.1 percentage of participants
Interval 0.6522 to 0.7651
|
70.5 percentage of participants
Interval 0.6467 to 0.7591
|
PRIMARY outcome
Timeframe: Pre-dose at Cycle 6 Day 1Population: Per Protocol-Pharmacokinetic (PP-PK) population: all randomized participants who met following: at least 11 Isa dose from Cycle 1 Day 1 to Cycle 5 Day 15 (1 dose omission permitted at Cycle 1 only); Isa pre-dose plasma concentration results from PK samples on Cycle 6 Day 1 collected within PP defined time window with adequate documentation of dosing and sampling dates and times.
Ctrough at steady state was the observed plasma concentration collected on pre-dose at Cycle 6 Day 1 (equivalent to prior to Cycle 6 Day 1) of isatuximab administration dose.
Outcome measures
| Measure |
Isa-SC + Pd
n=121 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=121 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Observed Concentration Before Dosing (Ctrough) of Isatuximab at Steady State
|
499 microgram/milliliter (mcg/mL)
Standard Deviation 259
|
340 microgram/milliliter (mcg/mL)
Standard Deviation 169
|
SECONDARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 monthsPopulation: The ITT population included all randomized population.
VGPR or better rate by IRC using 2016 IMWG criteria: Percentage of participants with sCR, CR, and VGPR. CR: negative immunofixation on serum and urine, disappearance of any STP, \<5% plasma cells in BM aspirates \& normal FLC ratio (0.26-1.65). sCR: CR plus no clonal cells in BM biopsy. VGPR: serum and urine M-protein detectable by immunofixation, not electrophoresis;\>=90% reduction in serum M-protein plus urine M-protein level\<100mg/24h;\>=90% decrease in SPD compared to baseline in STP; FLC only:\>=90% decrease in difference between involved and uninvolved FLC levels. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=263 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=268 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Very Good Partial Response or Better Rate
|
46.4 percentage of participants
|
45.9 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-dose at Cycle 2 Day 1 (at 4 weeks)Population: The CT4W-PK population: all randomized participants who met following: all 4 Isa doses for Cycle 1 administered; Isa pre-dose plasma concentration results from PK samples on Cycle 2 Day 1 collected within PP defined time window with adequate documentation of dosing and sampling dates and times.
The CT4W was the observed plasma concentrations collected on pre-dose at Cycle 2 Day 1 (equivalent to prior to Cycle 2 Day 1) of isatuximab administration dose.
Outcome measures
| Measure |
Isa-SC + Pd
n=131 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=126 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Ctrough of Isatuximab at 4 Weeks (CT4W)
|
421 mcg/mL
Standard Deviation 215
|
302 mcg/mL
Standard Deviation 117
|
SECONDARY outcome
Timeframe: From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 28 monthsPopulation: The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication.
Infusion reactions were graded using National Cancer Institute-Common Terminology Criteria for AE (NCI-CTCAE) version (v)5.0 criteria: Grade 1: mild transient reaction; infusion interruption not indicated; intervention not indicated. Grade 2: moderate reaction; therapy or infusion interruption indicated but responds promptly to symptomatic treatment; prophylactic medications indicated for \<=24 hours. Grade 3/4: severe or life-threatening reaction (Grade 3: prolonged \[not rapidly responsive to symptomatic medication and/or brief interruption of infusion\]; recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4: life-threatening consequences; urgent intervention indicated). Percentage of participants who observed AE of infusion reactions were collected through the electronic case report form (eCRF) as assessed by investigators. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=263 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=264 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants With Infusion Reactions
|
1.5 percentage of participants
Interval 0.42 to 3.85
|
25.0 percentage of participants
Interval 19.89 to 30.68
|
SECONDARY outcome
Timeframe: Cycle 5 Day 15Population: The ITT population included all randomized population.
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'satisfaction with injection method' were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints. The total percentage of participants who were very satisfied and satisfied with the injection method (item-8) at Cycle 5 Day 15 is reported here. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=263 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=268 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
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
|
70.0 percentage of participants
|
53.4 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 monthsPopulation: The ITT population included all randomized population. Only responders (participants who achieved a response of PR or better subsequently confirmed based on disease assessment by IRC) were included in the analysis.
DOR: Time from the date of first response to the date of first occurrence of progressive disease (PD) determined by IRC or death from any cause, whichever occurred first.DOR was determined only for participants who achieved a response (PR or better).If PD/death not observed, participant was censored at date of last valid disease assessment performed prior to initiating further anti-myeloma treatment or analysis cut-off date, whichever occurred first. As per IMWG criteria: PD: increase of \>=25% from lowest confirmed value in any 1 of following: serum M-protein (absolute increase\>=0.5 gram/deciliter\[g/dL\]),serum M-protein increase\>=1g/dL if lowest M-component \>=5g/dL, urine M-component (absolute increase \>=200mg/24h), appearance of new lesion(s),\>=50% increase from nadir in SPD of \>1 lesion or \>=50% increase in longest diameter of a previous lesion \>1 centimeter (cm) in short axis. PR: as defined in OM1.
Outcome measures
| Measure |
Isa-SC + Pd
n=187 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Duration of Response (DOR)
|
NA months
Interval 18.3 to
NA indicates that median and upper limit of CI were not estimable due to insufficient number of participants with events at PCD.
|
NA months
NA indicates that median, lower and upper limit of CI were not estimable due to insufficient number of participants with events at PCD.
|
SECONDARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 monthsPopulation: The ITT population included all randomized population.
TT1R was defined as the time from randomization to the date of first IRC determined response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as \>=50% reduction of serum M-protein and reduction in 24h urine M-protein by \>=90% or to \<200mg/24h. In addition to above, if present at baseline, \>=50% reduction in the size SPD of STPs was also required.
Outcome measures
| Measure |
Isa-SC + Pd
n=263 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=268 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Time to First Response (TT1R)
|
2.04 months
Interval 1.906 to 2.793
|
1.91 months
Interval 1.216 to 1.971
|
SECONDARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 monthsPopulation: The ITT population included all randomized population.
TTBR was defined as the time from randomization to the date of first occurrence of IRC determined best overall response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as \>=50% reduction of serum M-protein and reduction in 24h urine M-protein by \>=90% or to \<200mg/24h. In addition to above, if present at baseline,\>=50% reduction in the size SPD of STPs was also required.
Outcome measures
| Measure |
Isa-SC + Pd
n=263 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=268 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Time to Best Response (TTBR)
|
4.60 months
Interval 3.811 to 5.125
|
3.94 months
Interval 3.548 to 4.862
|
SECONDARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to a maximum of 57 monthsPFS is defined as the time from the date of randomization to the date of first documentation of PD as determined by IRC or the date of death from any cause, whichever came first. Responses will be determined according to IMWG criteria. PFS will be censored at the date of the last valid disease assessment not showing PD performed prior to initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever comes first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to a maximum of 57 monthsOS is defined as the time from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date will be censored at the last date the participant was known to be alive or the cut-off date, whichever is first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to a maximum of 57 monthsPFS2 is defined as time from the date of randomization to the date of first documentation of PD (as assessed by Investigator) after initiation of further anti-myeloma treatment or death from any cause, whichever happens first. Same censoring rule applies as in the PFS endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 monthsPopulation: The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication.
An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.
Outcome measures
| Measure |
Isa-SC + Pd
n=263 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=264 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
|
255 Participants
|
255 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
|
139 Participants
|
127 Participants
|
SECONDARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 monthsPopulation: The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication. As pre-specified in the protocol and statistical analysis plan (SAP), ISRs were evaluated only for Isa-SC + Pd arm.
The ISRs are defined as AEs related to medication administration with onset typically within 24 hours from the start of the infusion and are graded using NCI-CTCAE v5.0 criteria: Grade 1: tenderness with or without associated symptoms (warmth, erythema, itching). Grade 2: pain; lipodystrophy; edema; phlebitis. Grade 3: ulceration or necrosis severe tissue damage operative intervention indicated. Grade 4: life-threatening consequences; urgent intervention indicated. ISRs were collected through the eCRF. Number of participants with at least 1 ISR is reported. ISRs were applicable only for the SC administration.
Outcome measures
| Measure |
Isa-SC + Pd
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=263 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Isa-SC + Pd: Number of Participants With Injection Site Reactions (ISRs)
|
—
|
11 Participants
|
SECONDARY outcome
Timeframe: Pre-dose on Cycle 1 Days 8, 15 and 22, Cycles 2 to 5 Days 1 and 15, Cycles 6, 7, 8, 9, 12, 15, 18, 21, 24 and 27 Day 1Population: The PK population included all participants with at least 1 available isatuximab concentration post-baseline (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoints are reported.
Plasma samples were collected at specified timepoints for the assessment of Ctrough.
Outcome measures
| Measure |
Isa-SC + Pd
n=210 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=209 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Ctrough of Isatuximab
Cycle 6 Day 1
|
491 mcg/mL
Standard Deviation 256
|
330 mcg/mL
Standard Deviation 165
|
|
Ctrough of Isatuximab
Cycle 7 Day 1
|
523 mcg/mL
Standard Deviation 336
|
339 mcg/mL
Standard Deviation 189
|
|
Ctrough of Isatuximab
Cycle 8 Day 1
|
569 mcg/mL
Standard Deviation 336
|
348 mcg/mL
Standard Deviation 172
|
|
Ctrough of Isatuximab
Cycle 9 Day 1
|
598 mcg/mL
Standard Deviation 369
|
365 mcg/mL
Standard Deviation 193
|
|
Ctrough of Isatuximab
Cycle 12 Day 1
|
593 mcg/mL
Standard Deviation 404
|
380 mcg/mL
Standard Deviation 214
|
|
Ctrough of Isatuximab
Cycle 5 Day 1
|
470 mcg/mL
Standard Deviation 264
|
366 mcg/mL
Standard Deviation 568
|
|
Ctrough of Isatuximab
Cycle 15 Day 1
|
651 mcg/mL
Standard Deviation 361
|
354 mcg/mL
Standard Deviation 158
|
|
Ctrough of Isatuximab
Cycle 18 Day 1
|
645 mcg/mL
Standard Deviation 343
|
367 mcg/mL
Standard Deviation 140
|
|
Ctrough of Isatuximab
Cycle 21 Day 1
|
668 mcg/mL
Standard Deviation 213
|
388 mcg/mL
Standard Deviation 174
|
|
Ctrough of Isatuximab
Cycle 24 Day 1
|
651 mcg/mL
Standard Deviation 424
|
525 mcg/mL
Standard Deviation 455
|
|
Ctrough of Isatuximab
Cycle 27 Day 1
|
566 mcg/mL
Standard Deviation 200
|
—
|
|
Ctrough of Isatuximab
Cycle 3 Day 15
|
392 mcg/mL
Standard Deviation 245
|
256 mcg/mL
Standard Deviation 138
|
|
Ctrough of Isatuximab
Cycle 4 Day 1
|
477 mcg/mL
Standard Deviation 424
|
277 mcg/mL
Standard Deviation 151
|
|
Ctrough of Isatuximab
Cycle 5 Day 15
|
463 mcg/mL
Standard Deviation 275
|
306 mcg/mL
Standard Deviation 168
|
|
Ctrough of Isatuximab
Cycle 1 Day 22
|
321 mcg/mL
Standard Deviation 144
|
227 mcg/mL
Standard Deviation 99
|
|
Ctrough of Isatuximab
Cycle 2 Day 1
|
407 mcg/mL
Standard Deviation 211
|
293 mcg/mL
Standard Deviation 117
|
|
Ctrough of Isatuximab
Cycle 2 Day 15
|
363 mcg/mL
Standard Deviation 228
|
243 mcg/mL
Standard Deviation 130
|
|
Ctrough of Isatuximab
Cycle 3 Day 1
|
381 mcg/mL
Standard Deviation 192
|
268 mcg/mL
Standard Deviation 133
|
|
Ctrough of Isatuximab
Cycle 1 Day 8
|
129 mcg/mL
Standard Deviation 66
|
92 mcg/mL
Standard Deviation 47
|
|
Ctrough of Isatuximab
Cycle 1 Day 15
|
249 mcg/mL
Standard Deviation 115
|
171 mcg/mL
Standard Deviation 84
|
|
Ctrough of Isatuximab
Cycle 4 Day 15
|
452 mcg/mL
Standard Deviation 400
|
285 mcg/mL
Standard Deviation 139
|
SECONDARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 monthsPopulation: The safety population included ITT participants who received at least 1 dose or a part of a dose of the study medication. Total number of actual injections is reported as type of units.
Percentage of successful injections with investigational isatuximab injector device was defined as completion of administration per provided instructions for use with no use errors or technical issues divided by the total number of injections x 100. Delivery performance of the device was analyzed based on the successful injection rate in the Isa-SC + Pd arm as the investigational isatuximab injector device was used only for SC administration.
Outcome measures
| Measure |
Isa-SC + Pd
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=5145 Actual injections
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Isa-SC + Pd: Percentage of Successful Injections With Isatuximab Injector Device
|
—
|
98.8 percentage of successful injections
|
SECONDARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 monthsPopulation: The ADA population included all participants from safety population with at least 1 ADA result (negative, positive or inconclusive) post-baseline.
A participant with treatment-emergent ADA was a participant with at least 1 treatment induced or treatment boosted ADA at any time during the treatment or follow-up observation period. Treatment-induced ADA was defined as ADAs developed de novo (seroconversion) following administration of the biotherapeutic (ie, formation of ADAs any time after the initial study medication administration in a participant without pre-existing ADAs). Treatment-boosted ADA was defined as pre-existing ADAs that were boosted to a higher level following administration of biotherapeutic (ie, any time after the initial study medication administration) the ADA titer was significantly higher than the baseline titer. Number of participants with treatment-emergent ADAs is presented.
Outcome measures
| Measure |
Isa-SC + Pd
n=255 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=254 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Isatuximab
|
11 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1)Population: The ITT population included all randomized population. Only those participants with data collected at Baseline are reported.
Percentage of participants who responded that they strongly agree or agree at baseline with expectations of pain, discomfort and side effects from the injection method, the injection method would save time, study medication may result in side effects and would be worth taking are reported. PEQ-BL consisted of 7 items. Percentage of participants who ever received medication through IV and/or SC administration are also reported. Percentages are rounded off to the tenth decimal place. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=226 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=216 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Injection method may be painful: strongly agree
|
8.0 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Injection method may be painful: agree
|
33.2 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Injection method may be uncomfortable: strongly agree
|
9.7 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Injection method may be uncomfortable: agree
|
26.1 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Injection method may result in side effects: strongly agree
|
4.9 percentage of participants
|
9.3 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Injection method may result in side effects: agree
|
45.1 percentage of participants
|
42.6 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Study medication may result in side effects: agree
|
44.2 percentage of participants
|
47.2 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Study medication would be worth taking: strongly agree
|
27.0 percentage of participants
|
26.9 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Ever received medication through IV
|
61.9 percentage of participants
|
74.1 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Ever received medication through SC
|
61.1 percentage of participants
|
48.6 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Neither received medication ever via IV or SC
|
6.2 percentage of participants
|
9.3 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Injection method will save me time: agree
|
51.8 percentage of participants
|
31.5 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Study medication may result in side effects: strongly agree
|
8.0 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Injection method will save me time: strongly agree
|
21.2 percentage of participants
|
9.3 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'
Study medication would be worth taking: agree
|
47.8 percentage of participants
|
46.8 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'discomfort with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any discomfort with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=225 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=233 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 1 Day 8: disagree
|
39.5 percentage of participants
|
33.5 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 1 Day 8: strongly disagree
|
36.8 percentage of participants
|
14.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 1 Day 15: disagree
|
43.3 percentage of participants
|
38.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 2 Day 1: disagree
|
48.9 percentage of participants
|
40.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 2 Day 15: disagree
|
47.4 percentage of participants
|
40.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 2 Day 15: strongly disagree
|
34.0 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 4 Day 1: disagree
|
44.1 percentage of participants
|
35.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 4 Day 1: strongly disagree
|
37.6 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 5 Day 15: disagree
|
46.6 percentage of participants
|
38.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 6 Day 15: strongly disagree
|
39.9 percentage of participants
|
13.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 7 Day 15: disagree
|
41.2 percentage of participants
|
34.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 7 Day 15: strongly disagree
|
41.9 percentage of participants
|
16.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 8 Day 15: disagree
|
43.0 percentage of participants
|
35.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 8 Day 15: strongly disagree
|
38.3 percentage of participants
|
17.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 9 Day 15: disagree
|
41.9 percentage of participants
|
33.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 11 Day 15: disagree
|
41.5 percentage of participants
|
32.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 11 Day 15: strongly disagree
|
45.1 percentage of participants
|
16.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 12 Day 15: disagree
|
43.9 percentage of participants
|
32.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 13 Day 15: disagree
|
47.5 percentage of participants
|
35.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 14 Day 15: strongly disagree
|
44.2 percentage of participants
|
17.5 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 15 Day 15: disagree
|
37.5 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 15 Day 15: strongly disagree
|
45.8 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 17 Day 15: strongly disagree
|
48.4 percentage of participants
|
15.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 18 Day 15: disagree
|
48.0 percentage of participants
|
26.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 18 Day 15: strongly disagree
|
48.0 percentage of participants
|
21.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 19 Day 15: disagree
|
45.5 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 20 Day 15: strongly disagree
|
36.8 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 21 Day 15: strongly disagree
|
40.0 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 22 Day 15: disagree
|
66.7 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 26 Day 15: disagree
|
75.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 26 Day 15: strongly disagree
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 27 Day 15: disagree
|
100 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 27 Day 15: strongly disagree
|
0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 28 Day 15: disagree
|
100 percentage of participants
|
—
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 28 Day 15: strongly disagree
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 29 Day 15: strongly disagree
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 17 Day 15: disagree
|
41.9 percentage of participants
|
27.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 19 Day 15: strongly disagree
|
50.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 20 Day 15: disagree
|
57.9 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 21 Day 15: disagree
|
60.0 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 22 Day 15: strongly disagree
|
33.3 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 23 Day 15: disagree
|
66.7 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 23 Day 15: strongly disagree
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 24 Day 15: disagree
|
50.0 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 24 Day 15: strongly disagree
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 25 Day 15: disagree
|
75.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 25 Day 15: strongly disagree
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 29 Day 15: disagree
|
100 percentage of participants
|
—
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 1 Day 15: strongly disagree
|
37.9 percentage of participants
|
14.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 1 Day 22: disagree
|
44.2 percentage of participants
|
39.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 1 Day 22: strongly disagree
|
33.0 percentage of participants
|
12.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 2 Day 1: strongly disagree
|
32.0 percentage of participants
|
13.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 3 Day 1: disagree
|
44.4 percentage of participants
|
38.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 3 Day 1: strongly disagree
|
34.1 percentage of participants
|
13.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 5 Day 15: strongly disagree
|
31.7 percentage of participants
|
15.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 6 Day 15: disagree
|
43.5 percentage of participants
|
36.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 9 Day 15: strongly disagree
|
39.0 percentage of participants
|
19.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 10 Day 15: disagree
|
43.4 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 10 Day 15: strongly disagree
|
45.5 percentage of participants
|
13.5 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 12 Day 15: strongly disagree
|
39.4 percentage of participants
|
17.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 13 Day 15: strongly disagree
|
40.7 percentage of participants
|
13.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 14 Day 15: disagree
|
40.4 percentage of participants
|
26.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 16 Day 15: disagree
|
37.8 percentage of participants
|
26.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Cycle 16 Day 15: strongly disagree
|
51.4 percentage of participants
|
21.4 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'pain with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any pain with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=225 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=233 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 1 Day 8: disagree
|
42.7 percentage of participants
|
44.5 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 1 Day 8: strongly disagree
|
40.9 percentage of participants
|
20.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 1 Day 15: strongly disagree
|
40.4 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 1 Day 22: disagree
|
45.6 percentage of participants
|
43.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 1 Day 22: strongly disagree
|
36.9 percentage of participants
|
19.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 2 Day 1: disagree
|
51.6 percentage of participants
|
48.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 2 Day 1: strongly disagree
|
35.6 percentage of participants
|
17.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 3 Day 1: disagree
|
50.9 percentage of participants
|
44.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 3 Day 1: strongly disagree
|
36.9 percentage of participants
|
17.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 4 Day 1: strongly disagree
|
39.4 percentage of participants
|
18.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 6 Day 15: strongly disagree
|
42.9 percentage of participants
|
17.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 7 Day 15: disagree
|
45.3 percentage of participants
|
45.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 9 Day 15: strongly disagree
|
46.7 percentage of participants
|
23.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 10 Day 15: disagree
|
41.4 percentage of participants
|
47.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 10 Day 15: strongly disagree
|
52.5 percentage of participants
|
20.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 11 Day 15: disagree
|
40.2 percentage of participants
|
44.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 11 Day 15: strongly disagree
|
53.7 percentage of participants
|
18.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 12 Day 15: disagree
|
42.4 percentage of participants
|
47.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 13 Day 15: disagree
|
45.8 percentage of participants
|
46.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 14 Day 15: disagree
|
44.2 percentage of participants
|
35.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 14 Day 15: strongly disagree
|
44.2 percentage of participants
|
21.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 15 Day 15: disagree
|
41.7 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 15 Day 15: strongly disagree
|
47.9 percentage of participants
|
14.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 16 Day 15: disagree
|
40.5 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 16 Day 15: strongly disagree
|
51.4 percentage of participants
|
21.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 17 Day 15: disagree
|
51.6 percentage of participants
|
42.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 17 Day 15: strongly disagree
|
45.2 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 18 Day 15: disagree
|
40.0 percentage of participants
|
47.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 18 Day 15: strongly disagree
|
56.0 percentage of participants
|
21.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 19 Day 15: disagree
|
50.0 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 19 Day 15: strongly disagree
|
45.5 percentage of participants
|
20.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 20 Day 15: disagree
|
52.6 percentage of participants
|
31.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 20 Day 15: strongly disagree
|
47.4 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 21 Day 15: disagree
|
60.0 percentage of participants
|
58.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 21 Day 15: strongly disagree
|
40.0 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 22 Day 15: disagree
|
66.7 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 22 Day 15: strongly disagree
|
33.3 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 23 Day 15: disagree
|
66.7 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 23 Day 15: strongly disagree
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 24 Day 15: disagree
|
25.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 24 Day 15: strongly disagree
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 25 Day 15: disagree
|
75.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 25 Day 15: strongly disagree
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 27 Day 15: disagree
|
66.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 27 Day 15: strongly disagree
|
0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 28 Day 15: disagree
|
100 percentage of participants
|
—
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 29 Day 15: disagree
|
100 percentage of participants
|
—
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 29 Day 15: strongly disagree
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 2 Day 15: disagree
|
50.2 percentage of participants
|
47.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 8 Day 15: disagree
|
42.2 percentage of participants
|
40.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 1 Day 15: disagree
|
44.3 percentage of participants
|
47.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 2 Day 15: strongly disagree
|
37.3 percentage of participants
|
17.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 4 Day 1: disagree
|
46.5 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 5 Day 15: disagree
|
51.3 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 5 Day 15: strongly disagree
|
37.6 percentage of participants
|
17.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 6 Day 15: disagree
|
47.6 percentage of participants
|
44.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 7 Day 15: strongly disagree
|
43.9 percentage of participants
|
19.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 8 Day 15: strongly disagree
|
42.2 percentage of participants
|
20.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 9 Day 15: disagree
|
40.0 percentage of participants
|
44.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 12 Day 15: strongly disagree
|
43.9 percentage of participants
|
19.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 13 Day 15: strongly disagree
|
45.8 percentage of participants
|
16.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 26 Day 15: disagree
|
75.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 26 Day 15: strongly disagree
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Cycle 28 Day 15: strongly disagree
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'side effects with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any side effects with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=225 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=233 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 1 Day 8: disagree
|
46.8 percentage of participants
|
41.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 1 Day 8: strongly disagree
|
28.2 percentage of participants
|
17.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 1 Day 15: disagree
|
46.3 percentage of participants
|
40.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 1 Day 15: strongly disagree
|
25.1 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 1 Day 22: disagree
|
42.7 percentage of participants
|
44.5 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 1 Day 22: strongly disagree
|
23.3 percentage of participants
|
12.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 2 Day 15: disagree
|
49.8 percentage of participants
|
44.5 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 5 Day 15: disagree
|
49.2 percentage of participants
|
43.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 5 Day 15: strongly disagree
|
28.0 percentage of participants
|
15.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 6 Day 15: disagree
|
47.0 percentage of participants
|
45.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 6 Day 15: strongly disagree
|
33.3 percentage of participants
|
12.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 7 Day 15: disagree
|
48.0 percentage of participants
|
43.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 8 Day 15: disagree
|
43.0 percentage of participants
|
35.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 8 Day 15: strongly disagree
|
32.8 percentage of participants
|
21.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 9 Day 15: disagree
|
43.8 percentage of participants
|
33.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 9 Day 15: strongly disagree
|
39.0 percentage of participants
|
19.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 10 Day 15: disagree
|
36.4 percentage of participants
|
45.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 10 Day 15: strongly disagree
|
45.5 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 11 Day 15: disagree
|
35.4 percentage of participants
|
41.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 11 Day 15: strongly disagree
|
41.5 percentage of participants
|
16.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 12 Day 15: disagree
|
43.9 percentage of participants
|
45.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 12 Day 15: strongly disagree
|
34.8 percentage of participants
|
15.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 13 Day 15: disagree
|
47.5 percentage of participants
|
43.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 13 Day 15: strongly disagree
|
32.2 percentage of participants
|
13.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 14 Day 15: disagree
|
51.9 percentage of participants
|
31.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 14 Day 15: strongly disagree
|
32.7 percentage of participants
|
19.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 15 Day 15: disagree
|
43.8 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 15 Day 15: strongly disagree
|
41.7 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 2 Day 15: strongly disagree
|
25.4 percentage of participants
|
12.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 3 Day 1: disagree
|
48.1 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 2 Day 1: disagree
|
51.1 percentage of participants
|
45.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 2 Day 1: strongly disagree
|
24.0 percentage of participants
|
12.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 3 Day 1: strongly disagree
|
28.5 percentage of participants
|
13.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 4 Day 1: disagree
|
53.5 percentage of participants
|
42.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 4 Day 1: strongly disagree
|
25.8 percentage of participants
|
11.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 7 Day 15: strongly disagree
|
35.1 percentage of participants
|
14.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 16 Day 15: disagree
|
35.1 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 16 Day 15: strongly disagree
|
37.8 percentage of participants
|
23.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 17 Day 15: disagree
|
45.2 percentage of participants
|
42.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 17 Day 15: strongly disagree
|
41.9 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 18 Day 15: disagree
|
48.0 percentage of participants
|
34.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 18 Day 15: strongly disagree
|
32.0 percentage of participants
|
21.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 19 Day 15: disagree
|
54.5 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 19 Day 15: strongly disagree
|
36.4 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 20 Day 15: disagree
|
52.6 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 20 Day 15: strongly disagree
|
36.8 percentage of participants
|
31.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 21 Day 15: disagree
|
50.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 21 Day 15: strongly disagree
|
40.0 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 22 Day 15: disagree
|
66.7 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 22 Day 15: strongly disagree
|
22.2 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 23 Day 15: disagree
|
55.6 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 23 Day 15: strongly disagree
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 24 Day 15: disagree
|
25.0 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 24 Day 15: strongly disagree
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 25 Day 15: disagree
|
50.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 25 Day 15: strongly disagree
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 26 Day 15: disagree
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 26 Day 15: strongly disagree
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 27 Day 15: disagree
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 27 Day 15: strongly disagree
|
0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 28 Day 15: disagree
|
100 percentage of participants
|
—
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 28 Day 15: strongly disagree
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 29 Day 15: disagree
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Cycle 29 Day 15: strongly disagree
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'time saving with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who strongly agreed and agreed that they experienced time saving with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=225 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=233 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 1 Day 8: strongly agree
|
37.3 percentage of participants
|
5.5 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 2 Day 15: agree
|
48.3 percentage of participants
|
28.2 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 7 Day 15: strongly agree
|
41.9 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 7 Day 15: agree
|
40.5 percentage of participants
|
29.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 23 Day 15: agree
|
44.4 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 29 Day 15: agree
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 24 Day 15: strongly agree
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 24 Day 15: agree
|
50.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 25 Day 15: strongly agree
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 25 Day 15: agree
|
50.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 26 Day 15: strongly agree
|
50.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 26 Day 15: agree
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 27 Day 15: strongly agree
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 27 Day 15: agree
|
66.7 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 28 Day 15: strongly agree
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 28 Day 15: agree
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 29 Day 15: strongly agree
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 1 Day 8: agree
|
37.3 percentage of participants
|
21.1 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 1 Day 15: strongly agree
|
42.4 percentage of participants
|
3.4 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 1 Day 15: agree
|
38.4 percentage of participants
|
25.5 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 1 Day 22: strongly agree
|
35.9 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 1 Day 22: agree
|
46.1 percentage of participants
|
22.3 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 2 Day 1: strongly agree
|
35.1 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 2 Day 1: agree
|
46.2 percentage of participants
|
25.8 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 2 Day 15: strongly agree
|
33.0 percentage of participants
|
5.5 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 3 Day 1: strongly agree
|
39.3 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 3 Day 1: agree
|
46.3 percentage of participants
|
25.8 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 4 Day 1: strongly agree
|
37.6 percentage of participants
|
7.6 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 4 Day 1: agree
|
43.7 percentage of participants
|
22.4 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 5 Day 15: strongly agree
|
39.7 percentage of participants
|
9.9 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 5 Day 15: agree
|
43.4 percentage of participants
|
22.8 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 6 Day 15: strongly agree
|
39.9 percentage of participants
|
7.6 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 6 Day 15: agree
|
39.9 percentage of participants
|
28.5 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 8 Day 15: strongly agree
|
35.2 percentage of participants
|
12.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 8 Day 15: agree
|
45.3 percentage of participants
|
23.9 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 9 Day 15: strongly agree
|
47.6 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 9 Day 15: agree
|
34.3 percentage of participants
|
26.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 10 Day 15: strongly agree
|
42.4 percentage of participants
|
9.4 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 10 Day 15: agree
|
35.4 percentage of participants
|
26.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 11 Day 15: strongly agree
|
45.1 percentage of participants
|
6.5 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 11 Day 15: agree
|
37.8 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 12 Day 15: strongly agree
|
36.4 percentage of participants
|
11.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 12 Day 15: agree
|
42.4 percentage of participants
|
26.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 13 Day 15: strongly agree
|
44.1 percentage of participants
|
9.2 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 13 Day 15: agree
|
42.4 percentage of participants
|
26.2 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 14 Day 15: strongly agree
|
42.3 percentage of participants
|
12.3 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 14 Day 15: agree
|
40.4 percentage of participants
|
14.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 15 Day 15: strongly agree
|
41.7 percentage of participants
|
14.6 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 15 Day 15: agree
|
50.0 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 16 Day 15: strongly agree
|
48.6 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 16 Day 15: agree
|
37.8 percentage of participants
|
26.2 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 17 Day 15: strongly agree
|
51.6 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 17 Day 15: agree
|
35.5 percentage of participants
|
24.2 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 18 Day 15: strongly agree
|
56.0 percentage of participants
|
26.1 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 18 Day 15: agree
|
32.0 percentage of participants
|
26.1 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 19 Day 15: strongly agree
|
50.0 percentage of participants
|
20.8 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 19 Day 15: agree
|
40.9 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 20 Day 15: strongly agree
|
52.6 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 20 Day 15: agree
|
36.8 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 21 Day 15: strongly agree
|
50.0 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 21 Day 15: agree
|
30.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 22 Day 15: strongly agree
|
33.3 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 22 Day 15: agree
|
44.4 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Cycle 23 Day 15: strongly agree
|
33.3 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 6 to 29 Day 15Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'satisfaction with injection method' were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints. Percentage of participants who were very satisfied and satisfied with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=225 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=233 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 1 Day 15: satisfied
|
46.3 percentage of participants
|
51.4 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 10 Day 15: very satisfied
|
52.5 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 24 Day 15: very satisfied
|
50.0 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 1 Day 8: very satisfied
|
35.9 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 1 Day 8: satisfied
|
52.7 percentage of participants
|
52.8 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 1 Day 15: very satisfied
|
43.8 percentage of participants
|
16.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 1 Day 22: very satisfied
|
36.9 percentage of participants
|
9.5 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 1 Day 22: satisfied
|
51.9 percentage of participants
|
55.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 2 Day 1: very satisfied
|
39.6 percentage of participants
|
12.4 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 2 Day 1: satisfied
|
48.4 percentage of participants
|
51.9 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 2 Day 15: very satisfied
|
40.2 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 2 Day 15: satisfied
|
51.7 percentage of participants
|
54.5 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 3 Day 1: very satisfied
|
42.1 percentage of participants
|
13.4 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 3 Day 1: satisfied
|
48.1 percentage of participants
|
57.6 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 4 Day 1: very satisfied
|
43.2 percentage of participants
|
13.8 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 4 Day 1: satisfied
|
50.7 percentage of participants
|
55.7 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 6 Day 15: very satisfied
|
45.8 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 6 Day 15: satisfied
|
47.0 percentage of participants
|
54.1 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 7 Day 15: very satisfied
|
50.0 percentage of participants
|
17.4 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 7 Day 15: satisfied
|
45.3 percentage of participants
|
54.8 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 8 Day 15: very satisfied
|
45.3 percentage of participants
|
18.7 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 8 Day 15: satisfied
|
45.3 percentage of participants
|
49.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 9 Day 15: very satisfied
|
51.4 percentage of participants
|
20.7 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 9 Day 15: satisfied
|
43.8 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 10 Day 15: satisfied
|
41.4 percentage of participants
|
49.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 11 Day 15: very satisfied
|
56.1 percentage of participants
|
19.4 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 11 Day 15: satisfied
|
40.2 percentage of participants
|
48.4 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 12 Day 15: very satisfied
|
48.5 percentage of participants
|
17.8 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 12 Day 15: satisfied
|
45.5 percentage of participants
|
49.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 13 Day 15: very satisfied
|
50.8 percentage of participants
|
23.1 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 13 Day 15: satisfied
|
45.8 percentage of participants
|
50.8 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 14 Day 15: very satisfied
|
50.0 percentage of participants
|
24.6 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 14 Day 15: satisfied
|
42.3 percentage of participants
|
43.9 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 15 Day 15: very satisfied
|
56.3 percentage of participants
|
27.1 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 15 Day 15: satisfied
|
39.6 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 16 Day 15: very satisfied
|
54.1 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 16 Day 15: satisfied
|
45.9 percentage of participants
|
45.2 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 17 Day 15: very satisfied
|
51.6 percentage of participants
|
27.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 17 Day 15: satisfied
|
41.9 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 18 Day 15: very satisfied
|
60.0 percentage of participants
|
26.1 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 18 Day 15: satisfied
|
36.0 percentage of participants
|
52.2 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 19 Day 15: very satisfied
|
50.0 percentage of participants
|
29.2 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 19 Day 15: satisfied
|
50.0 percentage of participants
|
45.8 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 20 Day 15: very satisfied
|
52.6 percentage of participants
|
31.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 20 Day 15: satisfied
|
42.1 percentage of participants
|
43.8 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 21 Day 15: very satisfied
|
80.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 21 Day 15: satisfied
|
20.0 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 22 Day 15: very satisfied
|
44.4 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 22 Day 15: satisfied
|
55.6 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 23 Day 15: very satisfied
|
55.6 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 23 Day 15: satisfied
|
44.4 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 24 Day 15: satisfied
|
50.0 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 25 Day 15: very satisfied
|
50.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 25 Day 15: satisfied
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 26 Day 15: very satisfied
|
75.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 26 Day 15: satisfied
|
25.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 27 Day 15: very satisfied
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 27 Day 15: satisfied
|
66.7 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 28 Day 15: very satisfied
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 28 Day 15: satisfied
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 29 Day 15: very satisfied
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Cycle 29 Day 15: satisfied
|
100 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'side effects with study medication' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any side effects with study medication are reported here. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=225 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=233 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 1 Day 8: disagree
|
44.5 percentage of participants
|
35.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 1 Day 15: disagree
|
38.9 percentage of participants
|
38.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 1 Day 22: disagree
|
40.3 percentage of participants
|
41.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 2 Day 1: strongly disagree
|
23.1 percentage of participants
|
9.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 2 Day 15: strongly disagree
|
20.1 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 10 Day 15: disagree
|
36.4 percentage of participants
|
39.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 12 Day 15: disagree
|
42.4 percentage of participants
|
37.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 14 Day 15: disagree
|
50.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 16 Day 15: disagree
|
29.7 percentage of participants
|
31.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 16 Day 15: strongly disagree
|
40.5 percentage of participants
|
23.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 17 Day 15: disagree
|
45.2 percentage of participants
|
27.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 17 Day 15: strongly disagree
|
35.5 percentage of participants
|
27.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 21 Day 15: disagree
|
60.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 21 Day 15: strongly disagree
|
30.0 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 23 Day 15: disagree
|
44.4 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 24 Day 15: strongly disagree
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 25 Day 15: disagree
|
50.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 27 Day 15: disagree
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 29 Day 15: strongly disagree
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 1 Day 8: strongly disagree
|
25.0 percentage of participants
|
16.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 1 Day 15: strongly disagree
|
23.6 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 1 Day 22: strongly disagree
|
19.9 percentage of participants
|
9.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 2 Day 1: disagree
|
46.7 percentage of participants
|
37.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 2 Day 15: disagree
|
47.8 percentage of participants
|
41.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 3 Day 1: disagree
|
40.7 percentage of participants
|
40.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 3 Day 1: strongly disagree
|
27.1 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 4 Day 1: disagree
|
48.8 percentage of participants
|
39.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 4 Day 1: strongly disagree
|
23.0 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 5 Day 15: disagree
|
46.6 percentage of participants
|
39.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 5 Day 15: strongly disagree
|
25.9 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 6 Day 15: disagree
|
44.6 percentage of participants
|
39.5 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 6 Day 15: strongly disagree
|
28.6 percentage of participants
|
13.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 7 Day 15: disagree
|
41.2 percentage of participants
|
39.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 7 Day 15: strongly disagree
|
34.5 percentage of participants
|
14.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 8 Day 15: disagree
|
38.3 percentage of participants
|
33.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 8 Day 15: strongly disagree
|
31.3 percentage of participants
|
17.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 9 Day 15: disagree
|
43.8 percentage of participants
|
31.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 9 Day 15: strongly disagree
|
33.3 percentage of participants
|
17.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 10 Day 15: strongly disagree
|
41.4 percentage of participants
|
15.6 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 11 Day 15: disagree
|
31.7 percentage of participants
|
38.7 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 11 Day 15: strongly disagree
|
39.0 percentage of participants
|
16.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 12 Day 15: strongly disagree
|
31.8 percentage of participants
|
15.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 13 Day 15: disagree
|
39.0 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 13 Day 15: strongly disagree
|
33.9 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 14 Day 15: strongly disagree
|
28.8 percentage of participants
|
19.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 15 Day 15: disagree
|
39.6 percentage of participants
|
35.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 15 Day 15: strongly disagree
|
41.7 percentage of participants
|
22.9 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 18 Day 15: disagree
|
48.0 percentage of participants
|
26.1 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 18 Day 15: strongly disagree
|
36.0 percentage of participants
|
34.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 19 Day 15: disagree
|
50.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 19 Day 15: strongly disagree
|
31.8 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 20 Day 15: disagree
|
57.9 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 20 Day 15: strongly disagree
|
26.3 percentage of participants
|
31.3 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 22 Day 15: disagree
|
55.6 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 22 Day 15: strongly disagree
|
33.3 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 23 Day 15: strongly disagree
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 24 Day 15: disagree
|
25.0 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 25 Day 15: strongly disagree
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 26 Day 15: disagree
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 26 Day 15: strongly disagree
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 27 Day 15: strongly disagree
|
0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 28 Day 15: disagree
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 28 Day 15: strongly disagree
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Cycle 29 Day 15: disagree
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'study medication worth taking' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who strongly agreed and agreed that the study medication was worth taking are reported here. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=225 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=233 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 4 Day 1: agree
|
47.4 percentage of participants
|
54.8 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 5 Day 15: strongly agree
|
42.9 percentage of participants
|
25.2 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 5 Day 15: agree
|
50.3 percentage of participants
|
49.5 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 6 Day 15: strongly agree
|
41.1 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 6 Day 15: agree
|
48.8 percentage of participants
|
50.6 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 1 Day 15: strongly agree
|
33.0 percentage of participants
|
19.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 1 Day 22: strongly agree
|
30.6 percentage of participants
|
20.9 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 3 Day 1: agree
|
46.3 percentage of participants
|
53.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 7 Day 15: strongly agree
|
45.3 percentage of participants
|
25.2 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 7 Day 15: agree
|
44.6 percentage of participants
|
56.1 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 8 Day 15: strongly agree
|
40.6 percentage of participants
|
26.9 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 8 Day 15: agree
|
50.0 percentage of participants
|
52.2 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 12 Day 15: strongly agree
|
43.9 percentage of participants
|
28.8 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 12 Day 15: agree
|
47.0 percentage of participants
|
56.2 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 13 Day 15: strongly agree
|
40.7 percentage of participants
|
32.3 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 15 Day 15: strongly agree
|
54.2 percentage of participants
|
35.4 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 16 Day 15: strongly agree
|
45.9 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 16 Day 15: agree
|
48.6 percentage of participants
|
38.1 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 17 Day 15: strongly agree
|
51.6 percentage of participants
|
51.5 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 17 Day 15: agree
|
45.2 percentage of participants
|
30.3 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 19 Day 15: agree
|
40.9 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 20 Day 15: agree
|
36.8 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 21 Day 15: strongly agree
|
50.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 21 Day 15: agree
|
50.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 23 Day 15: agree
|
44.4 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 24 Day 15: strongly agree
|
50.0 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 24 Day 15: agree
|
50.0 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 25 Day 15: strongly agree
|
50.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 25 Day 15: agree
|
50.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 1 Day 15: agree
|
48.8 percentage of participants
|
51.4 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 1 Day 22: agree
|
47.1 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 2 Day 1: strongly agree
|
34.2 percentage of participants
|
21.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 1 Day 8: strongly agree
|
34.1 percentage of participants
|
17.9 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 1 Day 8: agree
|
42.3 percentage of participants
|
48.6 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 2 Day 1: agree
|
47.1 percentage of participants
|
48.9 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 2 Day 15: strongly agree
|
32.1 percentage of participants
|
21.4 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 2 Day 15: agree
|
50.7 percentage of participants
|
50.5 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 3 Day 1: strongly agree
|
43.0 percentage of participants
|
20.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 4 Day 1: strongly agree
|
39.0 percentage of participants
|
22.9 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 9 Day 15: strongly agree
|
43.8 percentage of participants
|
30.2 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 9 Day 15: agree
|
46.7 percentage of participants
|
49.1 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 10 Day 15: strongly agree
|
45.5 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 10 Day 15: agree
|
46.5 percentage of participants
|
51.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 11 Day 15: strongly agree
|
52.4 percentage of participants
|
24.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 11 Day 15: agree
|
36.6 percentage of participants
|
54.8 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 13 Day 15: agree
|
54.2 percentage of participants
|
49.2 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 14 Day 15: strongly agree
|
42.3 percentage of participants
|
40.4 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 14 Day 15: agree
|
50.0 percentage of participants
|
36.8 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 15 Day 15: agree
|
39.6 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 18 Day 15: strongly agree
|
60.0 percentage of participants
|
47.8 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 18 Day 15: agree
|
40.0 percentage of participants
|
34.8 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 19 Day 15: strongly agree
|
54.5 percentage of participants
|
45.8 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 20 Day 15: strongly agree
|
63.2 percentage of participants
|
43.8 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 22 Day 15: strongly agree
|
33.3 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 22 Day 15: agree
|
66.7 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 23 Day 15: strongly agree
|
55.6 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 26 Day 15: strongly agree
|
75.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 26 Day 15: agree
|
25.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 27 Day 15: strongly agree
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 27 Day 15: agree
|
66.7 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 28 Day 15: strongly agree
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 28 Day 15: agree
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 29 Day 15: strongly agree
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Cycle 29 Day 15: agree
|
100 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to satisfaction with study medication were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints. Percentage of participants who were very satisfied and satisfied with the study medication are reported here. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=225 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=233 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 1 Day 15: satisfied
|
47.8 percentage of participants
|
47.6 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 2 Day 15: satisfied
|
52.2 percentage of participants
|
57.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 3 Day 1: satisfied
|
49.5 percentage of participants
|
61.8 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 4 Day 1: satisfied
|
50.2 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 5 Day 15: very satisfied
|
46.0 percentage of participants
|
27.2 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 5 Day 15: satisfied
|
46.0 percentage of participants
|
55.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 6 Day 15: very satisfied
|
41.7 percentage of participants
|
26.2 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 6 Day 15: satisfied
|
46.4 percentage of participants
|
56.4 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 7 Day 15: very satisfied
|
45.9 percentage of participants
|
30.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 8 Day 15: very satisfied
|
43.8 percentage of participants
|
29.9 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 8 Day 15: satisfied
|
46.9 percentage of participants
|
55.2 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 9 Day 15: very satisfied
|
48.6 percentage of participants
|
35.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 9 Day 15: satisfied
|
43.8 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 10 Day 15: very satisfied
|
49.5 percentage of participants
|
32.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 10 Day 15: satisfied
|
43.4 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 11 Day 15: satisfied
|
42.7 percentage of participants
|
58.1 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 12 Day 15: very satisfied
|
39.4 percentage of participants
|
28.8 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 12 Day 15: satisfied
|
48.5 percentage of participants
|
56.2 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 13 Day 15: very satisfied
|
49.2 percentage of participants
|
36.9 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 13 Day 15: satisfied
|
42.4 percentage of participants
|
47.7 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 14 Day 15: very satisfied
|
46.2 percentage of participants
|
42.1 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 14 Day 15: satisfied
|
44.2 percentage of participants
|
45.6 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 16 Day 15: very satisfied
|
48.6 percentage of participants
|
45.2 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 16 Day 15: satisfied
|
45.9 percentage of participants
|
35.7 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 17 Day 15: satisfied
|
45.2 percentage of participants
|
39.4 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 18 Day 15: very satisfied
|
68.0 percentage of participants
|
43.5 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 18 Day 15: satisfied
|
28.0 percentage of participants
|
43.5 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 23 Day 15: satisfied
|
44.4 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 24 Day 15: very satisfied
|
50.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 24 Day 15: satisfied
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 25 Day 15: very satisfied
|
50.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 22 Day 15: satisfied
|
66.7 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 23 Day 15: very satisfied
|
55.6 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 25 Day 15: satisfied
|
50.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 26 Day 15: very satisfied
|
75.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 26 Day 15: satisfied
|
25.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 27 Day 15: very satisfied
|
66.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 27 Day 15: satisfied
|
33.3 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 28 Day 15: very satisfied
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 28 Day 15: satisfied
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 29 Day 15: very satisfied
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 29 Day 15: satisfied
|
100 percentage of participants
|
—
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 1 Day 8: very satisfied
|
29.5 percentage of participants
|
17.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 1 Day 8: satisfied
|
50.5 percentage of participants
|
56.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 1 Day 15: very satisfied
|
31.0 percentage of participants
|
21.2 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 1 Day 22: very satisfied
|
30.6 percentage of participants
|
15.6 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 1 Day 22: satisfied
|
48.1 percentage of participants
|
58.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 2 Day 1: very satisfied
|
31.1 percentage of participants
|
18.9 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 2 Day 1: satisfied
|
50.2 percentage of participants
|
53.6 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 2 Day 15: very satisfied
|
30.6 percentage of participants
|
20.5 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 3 Day 1: very satisfied
|
38.3 percentage of participants
|
18.9 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 4 Day 1: very satisfied
|
38.0 percentage of participants
|
21.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 7 Day 15: satisfied
|
47.3 percentage of participants
|
52.3 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 11 Day 15: very satisfied
|
50.0 percentage of participants
|
29.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 15 Day 15: very satisfied
|
56.3 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 15 Day 15: satisfied
|
37.5 percentage of participants
|
43.8 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 17 Day 15: very satisfied
|
51.6 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 19 Day 15: very satisfied
|
59.1 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 19 Day 15: satisfied
|
36.4 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 20 Day 15: very satisfied
|
42.1 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 20 Day 15: satisfied
|
52.6 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 21 Day 15: very satisfied
|
80.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 21 Day 15: satisfied
|
20.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Cycle 22 Day 15: very satisfied
|
33.3 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'recommendation of the study medication' were recorded as 'definitely yes, probably yes, unsure, probably not and definitely not' at specified timepoints. Percentage of participants who responded definitely yes and probably yes to the recommendation of study medication are reported here. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=225 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=233 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 1 Day 8: definitely yes
|
50.9 percentage of participants
|
24.8 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 2 Day 15: probably yes
|
39.2 percentage of participants
|
46.8 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 4 Day 1: probably yes
|
38.5 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 5 Day 15: definitely yes
|
58.7 percentage of participants
|
33.7 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 6 Day 15: definitely yes
|
57.1 percentage of participants
|
33.7 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 20 Day 15: definitely yes
|
68.4 percentage of participants
|
56.3 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 29 Day 15: probably yes
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 1 Day 8: probably yes
|
34.1 percentage of participants
|
43.1 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 1 Day 15: definitely yes
|
46.8 percentage of participants
|
29.3 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 1 Day 15: probably yes
|
36.9 percentage of participants
|
44.7 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 1 Day 22: definitely yes
|
46.6 percentage of participants
|
26.5 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 1 Day 22: probably yes
|
38.8 percentage of participants
|
46.9 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 2 Day 1: definitely yes
|
49.8 percentage of participants
|
25.8 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 2 Day 1: probably yes
|
36.4 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 2 Day 15: definitely yes
|
46.9 percentage of participants
|
26.8 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 3 Day 1: definitely yes
|
52.8 percentage of participants
|
28.1 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 3 Day 1: probably yes
|
37.4 percentage of participants
|
48.8 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 4 Day 1: definitely yes
|
53.1 percentage of participants
|
29.5 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 5 Day 15: probably yes
|
34.9 percentage of participants
|
48.0 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 6 Day 15: probably yes
|
38.1 percentage of participants
|
45.9 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 7 Day 15: definitely yes
|
58.1 percentage of participants
|
30.3 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 7 Day 15: probably yes
|
36.5 percentage of participants
|
47.7 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 8 Day 15: definitely yes
|
55.5 percentage of participants
|
39.6 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 8 Day 15: probably yes
|
37.5 percentage of participants
|
38.8 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 9 Day 15: definitely yes
|
60.0 percentage of participants
|
36.2 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 9 Day 15: probably yes
|
37.1 percentage of participants
|
43.1 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 10 Day 15: definitely yes
|
60.6 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 10 Day 15: probably yes
|
34.3 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 11 Day 15: definitely yes
|
64.6 percentage of participants
|
35.5 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 11 Day 15: probably yes
|
29.3 percentage of participants
|
38.7 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 12 Day 15: definitely yes
|
51.5 percentage of participants
|
31.5 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 12 Day 15: probably yes
|
40.9 percentage of participants
|
34.2 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 13 Day 15: definitely yes
|
62.7 percentage of participants
|
35.4 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 13 Day 15: probably yes
|
32.2 percentage of participants
|
35.4 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 14 Day 15: definitely yes
|
61.5 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 14 Day 15: probably yes
|
32.7 percentage of participants
|
31.6 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 15 Day 15: definitely yes
|
64.6 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 15 Day 15: probably yes
|
27.1 percentage of participants
|
31.3 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 16 Day 15: definitely yes
|
56.8 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 16 Day 15: probably yes
|
35.1 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 17 Day 15: definitely yes
|
54.8 percentage of participants
|
51.5 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 17 Day 15: probably yes
|
38.7 percentage of participants
|
12.1 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 18 Day 15: definitely yes
|
68.0 percentage of participants
|
43.5 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 18 Day 15: probably yes
|
28.0 percentage of participants
|
21.7 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 19 Day 15: definitely yes
|
63.6 percentage of participants
|
45.8 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 19 Day 15: probably yes
|
36.4 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 20 Day 15: probably yes
|
26.3 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 21 Day 15: definitely yes
|
60.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 21 Day 15: probably yes
|
30.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 22 Day 15: definitely yes
|
44.4 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 22 Day 15: probably yes
|
44.4 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 23 Day 15: definitely yes
|
66.7 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 23 Day 15: probably yes
|
22.2 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 24 Day 15: definitely yes
|
50.0 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 24 Day 15: probably yes
|
25.0 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 25 Day 15: definitely yes
|
50.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 25 Day 15: probably yes
|
25.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 26 Day 15: definitely yes
|
50.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 26 Day 15: probably yes
|
25.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 27 Day 15: definitely yes
|
33.3 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 27 Day 15: probably yes
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 28 Day 15: definitely yes
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 28 Day 15: probably yes
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Cycle 29 Day 15: definitely yes
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at EOT are reported.
The PESQ-EOT consisting of 17 items assessed participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation) and has been adapted based on qualitative interviews with oncology participants. In addition to the above, this questionnaire also includes additional items to assess whether participants received oncology medications in the past 2 years and if a participant received both IV and SC in the past 2 years, then participant preference on injection method (whether SC or IV). Percentage of participants with response to these additional items (received oncology medications in the past 2 years via IV/SC/both and if received both IV and SC; then the participant preference on injection method) are reported here. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=78 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=70 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants With Response to 'Patient Experience and Satisfaction End of Treatment Questionnaire (PESQ-EOT)'
Received oncology medications in the past 2 years via SC only
|
23.1 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Experience and Satisfaction End of Treatment Questionnaire (PESQ-EOT)'
If received via both IV and SC: Preference for injection method: SC
|
87.5 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Experience and Satisfaction End of Treatment Questionnaire (PESQ-EOT)'
Received oncology medications in the past 2 years via IV only
|
32.1 percentage of participants
|
58.6 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Experience and Satisfaction End of Treatment Questionnaire (PESQ-EOT)'
Received oncology medications in the past 2 years via both IV and SC
|
20.5 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Experience and Satisfaction End of Treatment Questionnaire (PESQ-EOT)'
If received via both IV and SC: Preference for injection method: IV
|
0 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Response to 'Patient Experience and Satisfaction End of Treatment Questionnaire (PESQ-EOT)'
If received via both IV and SC: No preference for injection method
|
12.5 percentage of participants
|
55.6 percentage of participants
|
SECONDARY outcome
Timeframe: EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at EOT for this endpoint are reported.
The 4-item PAT is an internally developed non-disease specific and self-administered assessment which has been debriefed with oncology patients during qualitative interviews. It provided participant insights on the benefits and disadvantages of treatment. Benefits and disadvantages were respectively rated on a 0-10 scale wherein 0=none (not beneficial at all or no disadvantages at all) and 10=maximum (extremely beneficial or extremely disadvantageous). Disadvantages vs benefits were rated on a scale of -3 to 3 wherein -3=disadvantages significantly outweigh the benefits, 0=equal benefits and disadvantages and 3=benefits significantly outweigh the disadvantages. Mean of benefits, disadvantages and disadvantages vs benefits is presented here.
Outcome measures
| Measure |
Isa-SC + Pd
n=77 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=70 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Participant Responses to Patient's Assessment of Treatment (PAT) Questionnaire
Disadvantages
|
3.7 score on a scale
Standard Deviation 2.6
|
4.3 score on a scale
Standard Deviation 2.6
|
|
Participant Responses to Patient's Assessment of Treatment (PAT) Questionnaire
Disadvantages vs benefits
|
1.2 score on a scale
Standard Deviation 1.8
|
0.5 score on a scale
Standard Deviation 2.0
|
|
Participant Responses to Patient's Assessment of Treatment (PAT) Questionnaire
Benefits
|
6.4 score on a scale
Standard Deviation 2.3
|
5.7 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1)Population: The ITT population included all randomized population. Only those participants with responses at Baseline are presented.
Healthcare utilization at baseline before study medication administration was collected via HRUPQ. The mean number of times in the past 6 months a participant received care in a clinic or hospital emergency room for any health issue including MM or due to MM and at-home care from a nurse or other health professional for any health issue including MM or due to MM is presented. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=74 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=51 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Health Resource Utilization and Productivity Questionnaire (HRUPQ): Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Received Care
In a clinic or hospital emergency room due to MM
|
4.2 number of times received care
Standard Deviation 4.2
|
4.4 number of times received care
Standard Deviation 3.3
|
|
Health Resource Utilization and Productivity Questionnaire (HRUPQ): Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Received Care
At-home from nurse or other health professional due to MM
|
3.9 number of times received care
Standard Deviation 3.6
|
4.7 number of times received care
Standard Deviation 5.9
|
|
Health Resource Utilization and Productivity Questionnaire (HRUPQ): Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Received Care
In a clinic or hospital emergency room for any health issue including MM
|
3.7 number of times received care
Standard Deviation 4.1
|
3.6 number of times received care
Standard Deviation 3.6
|
|
Health Resource Utilization and Productivity Questionnaire (HRUPQ): Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Received Care
At-home from nurse or other health professional for any health issue including MM
|
3.8 number of times received care
Standard Deviation 3.2
|
4.4 number of times received care
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1)Population: The ITT population included all randomized population. Only those participants with responses at Baseline are presented.
Healthcare utilization at baseline before study medication administration was collected via HRUPQ. The mean number of nights in the past 6 month a participant stayed in hospital for any health issue including MM or due to MM and stayed in intensive care unit (ICU) for any health issue including MM or due to MM is presented. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=62 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=50 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
HRUPQ: Baseline Healthcare Utilization: Number of Nights in the Past 6 Months a Participant Stayed in Hospital
Stayed in hospital for any health issue including MM
|
5.2 number of nights
Standard Deviation 9.0
|
7.2 number of nights
Standard Deviation 12.3
|
|
HRUPQ: Baseline Healthcare Utilization: Number of Nights in the Past 6 Months a Participant Stayed in Hospital
Stayed in hospital due to MM
|
6.5 number of nights
Standard Deviation 10.3
|
10.3 number of nights
Standard Deviation 20.2
|
|
HRUPQ: Baseline Healthcare Utilization: Number of Nights in the Past 6 Months a Participant Stayed in Hospital
Stayed in ICU for any health issue including MM
|
1.3 number of nights
Standard Deviation 0.5
|
5.0 number of nights
Standard Deviation 2.6
|
|
HRUPQ: Baseline Healthcare Utilization: Number of Nights in the Past 6 Months a Participant Stayed in Hospital
Stayed in ICU due to MM
|
3.0 number of nights
Standard Deviation 2.0
|
—
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1)Population: The ITT population included all randomized population. Only those participants with responses at Baseline are presented.
Healthcare utilization at baseline before study medication administration was collected via HRUPQ. The mean number of times in the past 6 months a participant consulted (had seen or talked to) following healthcare professionals: general doctor or primary care clinician (PCC) who treats a variety of illnesses for any health issue including MM or related to MM, physical or occupational therapist for any health issue including MM or related to MM, mental health professional (e.g. psychiatrist, psychologist, psychiatric nurse) for any health issue including MM or related to MM, medical doctor or clinician who specializes in particular medical disease or issue (specialist) for any health issue including MM or related to MM is presented. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=110 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=113 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
HRUPQ: Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Consulted a Healthcare Professional (HCP)
Mental health professional for health issue related to MM
|
4.4 number of times consulted a HCP
Standard Deviation 7.8
|
3.3 number of times consulted a HCP
Standard Deviation 2.4
|
|
HRUPQ: Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Consulted a Healthcare Professional (HCP)
Medical doctor or clinician (specialist) for health issue related to MM
|
4.2 number of times consulted a HCP
Standard Deviation 2.4
|
4.5 number of times consulted a HCP
Standard Deviation 3.0
|
|
HRUPQ: Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Consulted a Healthcare Professional (HCP)
General doctor or PCC for any health issue including MM
|
4.9 number of times consulted a HCP
Standard Deviation 5.4
|
4.5 number of times consulted a HCP
Standard Deviation 3.9
|
|
HRUPQ: Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Consulted a Healthcare Professional (HCP)
General doctor or PCC for health issue related to MM
|
5.3 number of times consulted a HCP
Standard Deviation 7.6
|
4.5 number of times consulted a HCP
Standard Deviation 3.9
|
|
HRUPQ: Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Consulted a Healthcare Professional (HCP)
Physical or occupational therapist for any health issue including MM
|
6.7 number of times consulted a HCP
Standard Deviation 9.7
|
6.3 number of times consulted a HCP
Standard Deviation 5.3
|
|
HRUPQ: Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Consulted a Healthcare Professional (HCP)
Physical or occupational therapist for health issue related to MM
|
5.0 number of times consulted a HCP
Standard Deviation 6.4
|
6.2 number of times consulted a HCP
Standard Deviation 5.4
|
|
HRUPQ: Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Consulted a Healthcare Professional (HCP)
Mental health professional for any health issue including MM
|
5.2 number of times consulted a HCP
Standard Deviation 7.4
|
3.2 number of times consulted a HCP
Standard Deviation 3.0
|
|
HRUPQ: Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Consulted a Healthcare Professional (HCP)
Medical doctor or clinician (specialist) for any health issue including MM
|
4.4 number of times consulted a HCP
Standard Deviation 3.3
|
4.2 number of times consulted a HCP
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: From Cycle 2 Day 1 up to EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population.
Medical resource utilization was collected through HRUPQ. Participants were asked to indicate the duration of their hospital visit (from arrival to departure) and the duration of post-treatment monitoring based on their most recent isatuximab administration. The median duration across all visits (starting from Cycle 2) was calculated and reported here.
Outcome measures
| Measure |
Isa-SC + Pd
n=263 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=268 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Duration of Hospital Visits for Treatment Administration and Duration of Post-Treatment Monitoring Based on HRUPQ
Duration of hospital visit
|
180.00 minutes
Interval 1.0 to 600.0
|
240.00 minutes
Interval 1.0 to 500.0
|
|
Duration of Hospital Visits for Treatment Administration and Duration of Post-Treatment Monitoring Based on HRUPQ
Duration of post-treatment monitoring
|
30.00 minutes
Interval 1.0 to 500.0
|
30.00 minutes
Interval 1.0 to 500.0
|
SECONDARY outcome
Timeframe: Cycle 1 Days 8, 15 and 22, Cycle 2 Day 1, Cycles 3 to 29 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
Medical resource utilization was collected through HRUPQ. Percentage of participants with healthcare professional visit not required by clinical trial since last isatuximab administration was recorded. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=208 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=224 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 13 Day 15
|
12.3 percentage of participants
|
16.9 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 14 Day 15
|
5.8 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 15 Day 15
|
12.5 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 16 Day 15
|
13.9 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 17 Day 15
|
16.7 percentage of participants
|
15.2 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 18 Day 15
|
12.0 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 19 Day 15
|
13.6 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 20 Day 15
|
15.8 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 21 Day 15
|
0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 22 Day 15
|
11.1 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 23 Day 15
|
22.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 24 Day 15
|
0 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 25 Day 15
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 26 Day 15
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 27 Day 15
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 29 Day 15
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
EOT visit
|
17.1 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 28 Day 15
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 9 Day 15
|
14.1 percentage of participants
|
11.6 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 10 Day 15
|
14.1 percentage of participants
|
10.9 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 11 Day 15
|
10.4 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 12 Day 15
|
10.9 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 2 Day 1
|
10.8 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 3 Day 15
|
11.5 percentage of participants
|
13.2 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 4 Day 15
|
8.5 percentage of participants
|
13.1 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 5 Day 15
|
7.3 percentage of participants
|
8.9 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 6 Day 15
|
9.2 percentage of participants
|
9.7 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 7 Day 15
|
9.2 percentage of participants
|
13.2 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 8 Day 15
|
14.6 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 1 Day 8
|
14.9 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 1 Day 15
|
9.2 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Cycle 1 Day 22
|
9.8 percentage of participants
|
11.7 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 monthsPopulation: The ITT population included all randomized population. Only those participants with data collected are reported.
Employment status was assessed via HRUPQ. Percentage of participants who ever retired during the study are reported. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=250 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=252 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants Who Ever Retired During the Study Based on HRUPQ
|
83.6 percentage of participants
|
81.7 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 monthsPopulation: The ITT population included all randomized population. Only participants who retired during the study were included in the analysis.
Employment status was assessed via HRUPQ. Percentage of participants who retired early due to MM are reported. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=209 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=206 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Percentage of Participants Who Retired Early Due to MM Based on HRUPQ
|
37.3 percentage of participants
|
32.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For GHS/QoL: overall health and quality of life were assessed, rated on a 7-point scale (1: very poor to 7: excellent). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for GHS/QoL and a positive change from baseline represents a healthy/better level of QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 2 Day 1
|
-1.52 score on a scale
Standard Deviation 17.79
|
-2.78 score on a scale
Standard Deviation 18.61
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 11 Day 15
|
-0.86 score on a scale
Standard Deviation 21.56
|
0.41 score on a scale
Standard Deviation 18.70
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 3 Day 15
|
-0.52 score on a scale
Standard Deviation 17.92
|
-0.56 score on a scale
Standard Deviation 19.15
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 4 Day 15
|
1.08 score on a scale
Standard Deviation 19.20
|
-0.05 score on a scale
Standard Deviation 19.16
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 5 Day 15
|
1.04 score on a scale
Standard Deviation 20.45
|
0.65 score on a scale
Standard Deviation 18.49
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 6 Day 15
|
2.80 score on a scale
Standard Deviation 19.56
|
0.34 score on a scale
Standard Deviation 18.13
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 7 Day 15
|
2.24 score on a scale
Standard Deviation 20.27
|
-0.06 score on a scale
Standard Deviation 20.56
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 8 Day 15
|
-0.61 score on a scale
Standard Deviation 20.56
|
2.85 score on a scale
Standard Deviation 17.06
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 9 Day 15
|
-0.99 score on a scale
Standard Deviation 20.39
|
1.42 score on a scale
Standard Deviation 20.55
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 10 Day 15
|
2.60 score on a scale
Standard Deviation 19.24
|
2.34 score on a scale
Standard Deviation 19.21
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 12 Day 15
|
0.65 score on a scale
Standard Deviation 23.85
|
2.56 score on a scale
Standard Deviation 19.37
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 13 Day 15
|
6.11 score on a scale
Standard Deviation 19.41
|
3.16 score on a scale
Standard Deviation 19.17
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 14 Day 15
|
0.19 score on a scale
Standard Deviation 22.75
|
4.33 score on a scale
Standard Deviation 19.07
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 15 Day 15
|
0.83 score on a scale
Standard Deviation 22.86
|
1.70 score on a scale
Standard Deviation 20.46
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 16 Day 15
|
2.42 score on a scale
Standard Deviation 26.54
|
4.06 score on a scale
Standard Deviation 16.87
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 17 Day 15
|
0.00 score on a scale
Standard Deviation 25.00
|
3.33 score on a scale
Standard Deviation 17.73
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 18 Day 15
|
2.08 score on a scale
Standard Deviation 25.20
|
4.58 score on a scale
Standard Deviation 17.20
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 19 Day 15
|
-6.37 score on a scale
Standard Deviation 20.74
|
2.65 score on a scale
Standard Deviation 20.80
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 20 Day 15
|
0.60 score on a scale
Standard Deviation 18.62
|
0.60 score on a scale
Standard Deviation 12.43
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Cycle 21 Day 15
|
3.13 score on a scale
Standard Deviation 16.63
|
-3.33 score on a scale
Standard Deviation 26.12
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
EOT visit
|
-4.11 score on a scale
Standard Deviation 24.06
|
-6.72 score on a scale
Standard Deviation 22.42
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of physical functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 7 Day 15
|
-1.64 score on a scale
Standard Deviation 17.63
|
-2.04 score on a scale
Standard Deviation 15.60
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 9 Day 15
|
-2.62 score on a scale
Standard Deviation 17.35
|
-1.93 score on a scale
Standard Deviation 16.80
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 2 Day 1
|
-2.10 score on a scale
Standard Deviation 15.32
|
-1.62 score on a scale
Standard Deviation 17.20
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 3 Day 15
|
-0.88 score on a scale
Standard Deviation 16.96
|
-1.98 score on a scale
Standard Deviation 15.74
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 4 Day 15
|
-1.33 score on a scale
Standard Deviation 18.67
|
-0.98 score on a scale
Standard Deviation 14.62
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 5 Day 15
|
-0.62 score on a scale
Standard Deviation 18.15
|
-1.41 score on a scale
Standard Deviation 15.23
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 6 Day 15
|
0.37 score on a scale
Standard Deviation 17.50
|
-1.10 score on a scale
Standard Deviation 14.82
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 8 Day 15
|
-0.55 score on a scale
Standard Deviation 19.82
|
-1.02 score on a scale
Standard Deviation 15.68
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 10 Day 15
|
-0.92 score on a scale
Standard Deviation 19.17
|
-0.81 score on a scale
Standard Deviation 15.16
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 11 Day 15
|
-2.45 score on a scale
Standard Deviation 17.31
|
-2.20 score on a scale
Standard Deviation 13.94
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 12 Day 15
|
-1.96 score on a scale
Standard Deviation 18.39
|
-0.51 score on a scale
Standard Deviation 12.60
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 13 Day 15
|
-4.00 score on a scale
Standard Deviation 19.46
|
0.11 score on a scale
Standard Deviation 14.27
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 14 Day 15
|
-4.50 score on a scale
Standard Deviation 18.73
|
1.07 score on a scale
Standard Deviation 12.22
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 15 Day 15
|
-2.33 score on a scale
Standard Deviation 23.12
|
-1.97 score on a scale
Standard Deviation 17.70
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 16 Day 15
|
-4.30 score on a scale
Standard Deviation 21.74
|
-0.17 score on a scale
Standard Deviation 18.89
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 17 Day 15
|
-4.00 score on a scale
Standard Deviation 25.24
|
-2.22 score on a scale
Standard Deviation 16.36
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 18 Day 15
|
-0.33 score on a scale
Standard Deviation 22.21
|
-3.00 score on a scale
Standard Deviation 17.77
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 19 Day 15
|
-7.84 score on a scale
Standard Deviation 11.84
|
-3.33 score on a scale
Standard Deviation 19.27
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 20 Day 15
|
-8.10 score on a scale
Standard Deviation 14.83
|
0.48 score on a scale
Standard Deviation 10.28
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Cycle 21 Day 15
|
-2.50 score on a scale
Standard Deviation 15.09
|
-6.67 score on a scale
Standard Deviation 16.33
|
|
Change From Baseline in EORTC QLQ-C30: Physical Functioning
EOT visit
|
-8.83 score on a scale
Standard Deviation 20.71
|
-7.96 score on a scale
Standard Deviation 21.45
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of role functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 9 Day 15
|
-6.55 score on a scale
Standard Deviation 29.27
|
-2.67 score on a scale
Standard Deviation 20.20
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 14 Day 15
|
-7.36 score on a scale
Standard Deviation 33.79
|
-2.33 score on a scale
Standard Deviation 16.50
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 20 Day 15
|
-13.10 score on a scale
Standard Deviation 22.81
|
-3.57 score on a scale
Standard Deviation 9.65
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 2 Day 1
|
-1.35 score on a scale
Standard Deviation 24.24
|
-4.59 score on a scale
Standard Deviation 22.67
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 3 Day 15
|
-1.24 score on a scale
Standard Deviation 26.68
|
-2.42 score on a scale
Standard Deviation 22.86
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 4 Day 15
|
1.57 score on a scale
Standard Deviation 26.48
|
-0.75 score on a scale
Standard Deviation 22.43
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 5 Day 15
|
-0.62 score on a scale
Standard Deviation 28.56
|
-2.71 score on a scale
Standard Deviation 20.70
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 6 Day 15
|
-0.57 score on a scale
Standard Deviation 27.43
|
-1.84 score on a scale
Standard Deviation 21.79
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 7 Day 15
|
0.00 score on a scale
Standard Deviation 28.30
|
-3.56 score on a scale
Standard Deviation 23.48
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 8 Day 15
|
-5.50 score on a scale
Standard Deviation 32.24
|
-1.35 score on a scale
Standard Deviation 20.98
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 10 Day 15
|
-1.25 score on a scale
Standard Deviation 27.40
|
-2.85 score on a scale
Standard Deviation 17.92
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 11 Day 15
|
-8.33 score on a scale
Standard Deviation 30.13
|
-2.44 score on a scale
Standard Deviation 17.98
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 12 Day 15
|
-5.88 score on a scale
Standard Deviation 28.64
|
-1.79 score on a scale
Standard Deviation 17.95
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 13 Day 15
|
-4.07 score on a scale
Standard Deviation 26.15
|
-1.15 score on a scale
Standard Deviation 17.06
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 15 Day 15
|
-12.08 score on a scale
Standard Deviation 32.68
|
-3.03 score on a scale
Standard Deviation 18.07
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 16 Day 15
|
-10.22 score on a scale
Standard Deviation 33.52
|
-2.99 score on a scale
Standard Deviation 17.88
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 17 Day 15
|
-12.00 score on a scale
Standard Deviation 37.74
|
-3.89 score on a scale
Standard Deviation 12.13
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 18 Day 15
|
-3.33 score on a scale
Standard Deviation 26.27
|
-3.33 score on a scale
Standard Deviation 15.86
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 19 Day 15
|
-9.80 score on a scale
Standard Deviation 19.60
|
-3.03 score on a scale
Standard Deviation 11.07
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
Cycle 21 Day 15
|
2.08 score on a scale
Standard Deviation 27.37
|
-11.67 score on a scale
Standard Deviation 20.86
|
|
Change From Baseline in EORTC QLQ-C30: Role Functioning
EOT visit
|
-8.92 score on a scale
Standard Deviation 26.70
|
-9.14 score on a scale
Standard Deviation 25.90
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of emotional functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 16 Day 15
|
-0.54 score on a scale
Standard Deviation 22.46
|
3.85 score on a scale
Standard Deviation 16.98
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 2 Day 1
|
2.28 score on a scale
Standard Deviation 17.85
|
-1.37 score on a scale
Standard Deviation 17.91
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 3 Day 15
|
1.10 score on a scale
Standard Deviation 19.02
|
0.71 score on a scale
Standard Deviation 14.50
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 4 Day 15
|
3.14 score on a scale
Standard Deviation 19.98
|
-0.27 score on a scale
Standard Deviation 17.52
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 5 Day 15
|
1.50 score on a scale
Standard Deviation 18.14
|
0.35 score on a scale
Standard Deviation 17.39
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 6 Day 15
|
1.37 score on a scale
Standard Deviation 19.00
|
1.84 score on a scale
Standard Deviation 17.28
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 7 Day 15
|
0.58 score on a scale
Standard Deviation 20.81
|
0.64 score on a scale
Standard Deviation 19.57
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 8 Day 15
|
1.07 score on a scale
Standard Deviation 19.38
|
2.18 score on a scale
Standard Deviation 18.21
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 9 Day 15
|
1.59 score on a scale
Standard Deviation 23.48
|
0.33 score on a scale
Standard Deviation 18.72
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 10 Day 15
|
3.44 score on a scale
Standard Deviation 19.96
|
1.32 score on a scale
Standard Deviation 17.78
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 11 Day 15
|
3.31 score on a scale
Standard Deviation 23.88
|
0.10 score on a scale
Standard Deviation 18.63
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 12 Day 15
|
4.74 score on a scale
Standard Deviation 23.29
|
1.92 score on a scale
Standard Deviation 18.79
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 13 Day 15
|
-0.37 score on a scale
Standard Deviation 23.16
|
3.02 score on a scale
Standard Deviation 18.71
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 14 Day 15
|
-0.78 score on a scale
Standard Deviation 22.70
|
6.00 score on a scale
Standard Deviation 19.49
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 15 Day 15
|
-0.21 score on a scale
Standard Deviation 23.30
|
3.22 score on a scale
Standard Deviation 19.87
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 17 Day 15
|
-1.33 score on a scale
Standard Deviation 27.18
|
1.11 score on a scale
Standard Deviation 15.43
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 18 Day 15
|
-1.67 score on a scale
Standard Deviation 19.79
|
4.58 score on a scale
Standard Deviation 14.68
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 19 Day 15
|
-7.84 score on a scale
Standard Deviation 20.30
|
3.03 score on a scale
Standard Deviation 17.36
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 20 Day 15
|
-6.55 score on a scale
Standard Deviation 18.25
|
2.38 score on a scale
Standard Deviation 21.29
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Cycle 21 Day 15
|
3.13 score on a scale
Standard Deviation 15.39
|
3.33 score on a scale
Standard Deviation 16.29
|
|
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
EOT visit
|
-2.93 score on a scale
Standard Deviation 20.42
|
-5.24 score on a scale
Standard Deviation 18.31
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of cognitive functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 4 Day 15
|
0.88 score on a scale
Standard Deviation 17.70
|
-1.07 score on a scale
Standard Deviation 18.71
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 20 Day 15
|
-13.10 score on a scale
Standard Deviation 16.25
|
-8.33 score on a scale
Standard Deviation 16.98
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 2 Day 1
|
0.08 score on a scale
Standard Deviation 19.53
|
-1.32 score on a scale
Standard Deviation 16.03
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 3 Day 15
|
-2.00 score on a scale
Standard Deviation 19.43
|
-1.21 score on a scale
Standard Deviation 18.37
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 5 Day 15
|
0.00 score on a scale
Standard Deviation 18.91
|
-2.51 score on a scale
Standard Deviation 16.68
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 6 Day 15
|
-0.23 score on a scale
Standard Deviation 17.62
|
-2.30 score on a scale
Standard Deviation 16.85
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 7 Day 15
|
-1.03 score on a scale
Standard Deviation 18.65
|
-1.78 score on a scale
Standard Deviation 17.69
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 8 Day 15
|
-1.99 score on a scale
Standard Deviation 20.75
|
-2.40 score on a scale
Standard Deviation 15.55
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 9 Day 15
|
1.39 score on a scale
Standard Deviation 17.59
|
-3.50 score on a scale
Standard Deviation 17.13
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 10 Day 15
|
-0.42 score on a scale
Standard Deviation 19.84
|
-4.47 score on a scale
Standard Deviation 16.37
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 11 Day 15
|
0.49 score on a scale
Standard Deviation 19.94
|
-5.89 score on a scale
Standard Deviation 18.21
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 12 Day 15
|
3.27 score on a scale
Standard Deviation 21.35
|
-4.62 score on a scale
Standard Deviation 18.28
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 13 Day 15
|
0.74 score on a scale
Standard Deviation 20.09
|
-4.02 score on a scale
Standard Deviation 16.90
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 14 Day 15
|
-2.71 score on a scale
Standard Deviation 21.19
|
-4.00 score on a scale
Standard Deviation 20.64
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 15 Day 15
|
-1.25 score on a scale
Standard Deviation 19.75
|
-6.44 score on a scale
Standard Deviation 24.17
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 16 Day 15
|
-3.76 score on a scale
Standard Deviation 17.06
|
-3.42 score on a scale
Standard Deviation 21.69
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 17 Day 15
|
-6.67 score on a scale
Standard Deviation 22.05
|
-2.78 score on a scale
Standard Deviation 16.43
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 18 Day 15
|
-5.00 score on a scale
Standard Deviation 12.21
|
-9.17 score on a scale
Standard Deviation 17.50
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 19 Day 15
|
-11.76 score on a scale
Standard Deviation 15.33
|
-6.82 score on a scale
Standard Deviation 15.99
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Cycle 21 Day 15
|
-4.17 score on a scale
Standard Deviation 14.77
|
-18.33 score on a scale
Standard Deviation 18.34
|
|
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
EOT visit
|
-0.23 score on a scale
Standard Deviation 26.50
|
-8.33 score on a scale
Standard Deviation 24.66
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of social functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 15 Day 15
|
1.25 score on a scale
Standard Deviation 27.58
|
4.17 score on a scale
Standard Deviation 20.69
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 18 Day 15
|
-2.50 score on a scale
Standard Deviation 18.16
|
7.50 score on a scale
Standard Deviation 16.64
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 2 Day 1
|
0.17 score on a scale
Standard Deviation 21.23
|
-0.88 score on a scale
Standard Deviation 21.66
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 3 Day 15
|
2.38 score on a scale
Standard Deviation 24.35
|
-0.51 score on a scale
Standard Deviation 21.73
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 4 Day 15
|
2.06 score on a scale
Standard Deviation 25.01
|
-0.11 score on a scale
Standard Deviation 20.08
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 5 Day 15
|
1.24 score on a scale
Standard Deviation 23.98
|
0.40 score on a scale
Standard Deviation 22.69
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 6 Day 15
|
1.48 score on a scale
Standard Deviation 23.81
|
-0.92 score on a scale
Standard Deviation 24.75
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 7 Day 15
|
2.82 score on a scale
Standard Deviation 25.43
|
1.53 score on a scale
Standard Deviation 23.15
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 8 Day 15
|
0.76 score on a scale
Standard Deviation 24.89
|
0.75 score on a scale
Standard Deviation 23.50
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 9 Day 15
|
-0.79 score on a scale
Standard Deviation 22.98
|
3.67 score on a scale
Standard Deviation 24.46
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 10 Day 15
|
0.21 score on a scale
Standard Deviation 21.30
|
0.61 score on a scale
Standard Deviation 24.07
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 11 Day 15
|
2.45 score on a scale
Standard Deviation 25.31
|
-0.61 score on a scale
Standard Deviation 23.05
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 12 Day 15
|
0.65 score on a scale
Standard Deviation 24.94
|
4.10 score on a scale
Standard Deviation 24.30
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 13 Day 15
|
3.33 score on a scale
Standard Deviation 22.08
|
2.30 score on a scale
Standard Deviation 21.73
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 14 Day 15
|
-2.33 score on a scale
Standard Deviation 22.59
|
3.33 score on a scale
Standard Deviation 19.05
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 16 Day 15
|
-1.08 score on a scale
Standard Deviation 22.33
|
4.27 score on a scale
Standard Deviation 20.49
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 17 Day 15
|
5.33 score on a scale
Standard Deviation 25.33
|
6.11 score on a scale
Standard Deviation 22.09
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 19 Day 15
|
-0.98 score on a scale
Standard Deviation 25.32
|
8.33 score on a scale
Standard Deviation 18.37
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 20 Day 15
|
-3.57 score on a scale
Standard Deviation 22.81
|
8.33 score on a scale
Standard Deviation 23.34
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
Cycle 21 Day 15
|
18.75 score on a scale
Standard Deviation 28.78
|
6.67 score on a scale
Standard Deviation 22.50
|
|
Change From Baseline in EORTC QLQ-C30: Social Functioning
EOT visit
|
-4.93 score on a scale
Standard Deviation 32.90
|
-4.84 score on a scale
Standard Deviation 22.26
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 3 Day 15
|
2.41 score on a scale
Standard Deviation 20.28
|
3.91 score on a scale
Standard Deviation 21.49
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 7 Day 15
|
0.77 score on a scale
Standard Deviation 20.90
|
0.93 score on a scale
Standard Deviation 18.80
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 9 Day 15
|
2.25 score on a scale
Standard Deviation 21.11
|
1.89 score on a scale
Standard Deviation 22.11
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 17 Day 15
|
-0.44 score on a scale
Standard Deviation 25.56
|
3.70 score on a scale
Standard Deviation 20.91
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 2 Day 1
|
4.00 score on a scale
Standard Deviation 19.91
|
3.64 score on a scale
Standard Deviation 20.33
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 4 Day 15
|
1.18 score on a scale
Standard Deviation 20.16
|
0.71 score on a scale
Standard Deviation 19.70
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 5 Day 15
|
0.97 score on a scale
Standard Deviation 20.62
|
1.41 score on a scale
Standard Deviation 19.04
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 6 Day 15
|
0.53 score on a scale
Standard Deviation 20.85
|
-0.92 score on a scale
Standard Deviation 20.05
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 8 Day 15
|
2.85 score on a scale
Standard Deviation 24.45
|
0.10 score on a scale
Standard Deviation 18.98
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 10 Day 15
|
1.39 score on a scale
Standard Deviation 20.49
|
-0.41 score on a scale
Standard Deviation 22.12
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 11 Day 15
|
2.61 score on a scale
Standard Deviation 19.40
|
2.30 score on a scale
Standard Deviation 20.49
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 12 Day 15
|
-1.09 score on a scale
Standard Deviation 19.28
|
0.17 score on a scale
Standard Deviation 17.29
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 13 Day 15
|
2.22 score on a scale
Standard Deviation 19.04
|
-3.07 score on a scale
Standard Deviation 19.72
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 14 Day 15
|
3.62 score on a scale
Standard Deviation 20.39
|
-3.33 score on a scale
Standard Deviation 18.54
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 15 Day 15
|
2.78 score on a scale
Standard Deviation 21.61
|
0.00 score on a scale
Standard Deviation 20.47
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 16 Day 15
|
5.02 score on a scale
Standard Deviation 21.44
|
1.42 score on a scale
Standard Deviation 23.94
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 18 Day 15
|
-1.67 score on a scale
Standard Deviation 16.63
|
1.67 score on a scale
Standard Deviation 17.01
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 19 Day 15
|
3.92 score on a scale
Standard Deviation 18.40
|
8.08 score on a scale
Standard Deviation 18.84
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 20 Day 15
|
5.56 score on a scale
Standard Deviation 17.84
|
11.90 score on a scale
Standard Deviation 18.21
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
Cycle 21 Day 15
|
-6.94 score on a scale
Standard Deviation 25.15
|
14.44 score on a scale
Standard Deviation 26.22
|
|
Change From Baseline in EORTC QLQ-C30: Fatigue
EOT visit
|
3.44 score on a scale
Standard Deviation 22.89
|
7.89 score on a scale
Standard Deviation 26.18
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 5 Day 15
|
0.00 score on a scale
Standard Deviation 13.31
|
-1.20 score on a scale
Standard Deviation 11.97
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 12 Day 15
|
1.31 score on a scale
Standard Deviation 11.95
|
-1.03 score on a scale
Standard Deviation 14.70
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 13 Day 15
|
0.74 score on a scale
Standard Deviation 16.27
|
-2.87 score on a scale
Standard Deviation 14.35
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 2 Day 1
|
1.18 score on a scale
Standard Deviation 12.31
|
0.44 score on a scale
Standard Deviation 13.14
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 3 Day 15
|
-0.67 score on a scale
Standard Deviation 13.29
|
-2.22 score on a scale
Standard Deviation 10.34
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 4 Day 15
|
0.49 score on a scale
Standard Deviation 14.09
|
-1.92 score on a scale
Standard Deviation 11.19
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 6 Day 15
|
0.57 score on a scale
Standard Deviation 10.43
|
-2.76 score on a scale
Standard Deviation 11.62
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 7 Day 15
|
-0.26 score on a scale
Standard Deviation 12.45
|
-1.27 score on a scale
Standard Deviation 11.06
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 8 Day 15
|
-0.46 score on a scale
Standard Deviation 14.07
|
-0.90 score on a scale
Standard Deviation 11.42
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 9 Day 15
|
-0.79 score on a scale
Standard Deviation 11.25
|
0.33 score on a scale
Standard Deviation 14.41
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 10 Day 15
|
-0.21 score on a scale
Standard Deviation 14.16
|
0.41 score on a scale
Standard Deviation 11.70
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 11 Day 15
|
0.25 score on a scale
Standard Deviation 13.66
|
-1.63 score on a scale
Standard Deviation 16.06
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 14 Day 15
|
3.10 score on a scale
Standard Deviation 15.96
|
-1.67 score on a scale
Standard Deviation 17.90
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 15 Day 15
|
-0.83 score on a scale
Standard Deviation 12.49
|
-1.14 score on a scale
Standard Deviation 15.42
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 16 Day 15
|
1.08 score on a scale
Standard Deviation 15.48
|
-2.14 score on a scale
Standard Deviation 12.20
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 17 Day 15
|
1.33 score on a scale
Standard Deviation 19.20
|
1.11 score on a scale
Standard Deviation 12.33
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 18 Day 15
|
0.00 score on a scale
Standard Deviation 5.41
|
0.83 score on a scale
Standard Deviation 12.65
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 19 Day 15
|
1.96 score on a scale
Standard Deviation 10.00
|
0.76 score on a scale
Standard Deviation 19.57
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 20 Day 15
|
1.19 score on a scale
Standard Deviation 10.26
|
-2.38 score on a scale
Standard Deviation 12.84
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Cycle 21 Day 15
|
-2.08 score on a scale
Standard Deviation 13.91
|
1.67 score on a scale
Standard Deviation 18.34
|
|
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
EOT visit
|
-2.35 score on a scale
Standard Deviation 16.74
|
2.96 score on a scale
Standard Deviation 22.69
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 5 Day 15
|
-8.70 score on a scale
Standard Deviation 26.09
|
-6.22 score on a scale
Standard Deviation 21.82
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 2 Day 1
|
-5.84 score on a scale
Standard Deviation 24.48
|
-3.79 score on a scale
Standard Deviation 26.72
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 3 Day 15
|
-8.76 score on a scale
Standard Deviation 25.88
|
-6.36 score on a scale
Standard Deviation 22.50
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 4 Day 15
|
-6.57 score on a scale
Standard Deviation 25.21
|
-7.48 score on a scale
Standard Deviation 19.70
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 6 Day 15
|
-8.22 score on a scale
Standard Deviation 26.42
|
-6.90 score on a scale
Standard Deviation 21.57
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 7 Day 15
|
-8.46 score on a scale
Standard Deviation 28.70
|
-6.49 score on a scale
Standard Deviation 22.98
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 8 Day 15
|
-2.75 score on a scale
Standard Deviation 26.21
|
-7.51 score on a scale
Standard Deviation 20.19
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 9 Day 15
|
-3.17 score on a scale
Standard Deviation 26.82
|
-11.00 score on a scale
Standard Deviation 23.83
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 10 Day 15
|
-6.67 score on a scale
Standard Deviation 28.39
|
-7.32 score on a scale
Standard Deviation 22.24
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 11 Day 15
|
-7.60 score on a scale
Standard Deviation 26.30
|
-6.30 score on a scale
Standard Deviation 22.78
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 12 Day 15
|
-7.52 score on a scale
Standard Deviation 27.14
|
-6.41 score on a scale
Standard Deviation 24.06
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 13 Day 15
|
-5.93 score on a scale
Standard Deviation 28.24
|
-6.03 score on a scale
Standard Deviation 22.01
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 14 Day 15
|
-1.16 score on a scale
Standard Deviation 31.37
|
-9.00 score on a scale
Standard Deviation 19.11
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 15 Day 15
|
-3.33 score on a scale
Standard Deviation 29.77
|
-3.79 score on a scale
Standard Deviation 19.64
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 16 Day 15
|
-4.30 score on a scale
Standard Deviation 29.18
|
-4.70 score on a scale
Standard Deviation 22.28
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 17 Day 15
|
-3.33 score on a scale
Standard Deviation 37.58
|
-1.67 score on a scale
Standard Deviation 21.15
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 18 Day 15
|
-2.50 score on a scale
Standard Deviation 28.24
|
-4.17 score on a scale
Standard Deviation 20.14
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 19 Day 15
|
-0.98 score on a scale
Standard Deviation 25.32
|
0.00 score on a scale
Standard Deviation 23.57
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 20 Day 15
|
1.19 score on a scale
Standard Deviation 28.09
|
-1.19 score on a scale
Standard Deviation 20.11
|
|
Change From Baseline in EORTC QLQ-C30: Pain
Cycle 21 Day 15
|
-12.50 score on a scale
Standard Deviation 24.80
|
6.67 score on a scale
Standard Deviation 22.50
|
|
Change From Baseline in EORTC QLQ-C30: Pain
EOT visit
|
4.69 score on a scale
Standard Deviation 23.43
|
-0.81 score on a scale
Standard Deviation 33.26
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 2 Day 1
|
3.72 score on a scale
Standard Deviation 21.50
|
5.11 score on a scale
Standard Deviation 22.35
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 3 Day 15
|
1.33 score on a scale
Standard Deviation 22.13
|
6.87 score on a scale
Standard Deviation 25.10
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 4 Day 15
|
1.96 score on a scale
Standard Deviation 20.09
|
4.91 score on a scale
Standard Deviation 22.97
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 5 Day 15
|
3.73 score on a scale
Standard Deviation 21.41
|
3.01 score on a scale
Standard Deviation 24.84
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 6 Day 15
|
3.20 score on a scale
Standard Deviation 19.70
|
4.60 score on a scale
Standard Deviation 23.77
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 7 Day 15
|
3.08 score on a scale
Standard Deviation 19.22
|
5.09 score on a scale
Standard Deviation 24.28
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 8 Day 15
|
5.81 score on a scale
Standard Deviation 21.20
|
7.81 score on a scale
Standard Deviation 25.80
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 9 Day 15
|
4.76 score on a scale
Standard Deviation 20.79
|
7.33 score on a scale
Standard Deviation 24.88
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 10 Day 15
|
3.33 score on a scale
Standard Deviation 19.56
|
5.28 score on a scale
Standard Deviation 17.74
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 11 Day 15
|
4.41 score on a scale
Standard Deviation 19.02
|
8.13 score on a scale
Standard Deviation 22.57
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 12 Day 15
|
6.54 score on a scale
Standard Deviation 24.96
|
6.67 score on a scale
Standard Deviation 22.20
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 13 Day 15
|
8.15 score on a scale
Standard Deviation 22.65
|
7.47 score on a scale
Standard Deviation 23.40
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 14 Day 15
|
5.43 score on a scale
Standard Deviation 22.92
|
6.00 score on a scale
Standard Deviation 23.99
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 15 Day 15
|
8.33 score on a scale
Standard Deviation 23.57
|
9.85 score on a scale
Standard Deviation 22.25
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 16 Day 15
|
7.53 score on a scale
Standard Deviation 22.29
|
5.98 score on a scale
Standard Deviation 24.03
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 17 Day 15
|
6.67 score on a scale
Standard Deviation 21.52
|
10.00 score on a scale
Standard Deviation 17.83
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 18 Day 15
|
8.33 score on a scale
Standard Deviation 23.88
|
6.67 score on a scale
Standard Deviation 23.20
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 19 Day 15
|
17.65 score on a scale
Standard Deviation 31.44
|
7.58 score on a scale
Standard Deviation 22.84
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 20 Day 15
|
4.76 score on a scale
Standard Deviation 17.82
|
4.76 score on a scale
Standard Deviation 25.68
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
Cycle 21 Day 15
|
0.00 score on a scale
Standard Deviation 17.82
|
16.67 score on a scale
Standard Deviation 36.00
|
|
Change From Baseline in EORTC QLQ-C30: Dyspnea
EOT visit
|
4.23 score on a scale
Standard Deviation 21.77
|
9.14 score on a scale
Standard Deviation 26.43
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 2 Day 1
|
-3.89 score on a scale
Standard Deviation 27.39
|
0.71 score on a scale
Standard Deviation 27.71
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 3 Day 15
|
-4.57 score on a scale
Standard Deviation 29.33
|
-4.24 score on a scale
Standard Deviation 26.84
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 4 Day 15
|
-8.04 score on a scale
Standard Deviation 30.24
|
-5.34 score on a scale
Standard Deviation 25.54
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 5 Day 15
|
-2.90 score on a scale
Standard Deviation 30.14
|
-4.62 score on a scale
Standard Deviation 29.11
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 6 Day 15
|
-4.57 score on a scale
Standard Deviation 28.40
|
-3.68 score on a scale
Standard Deviation 27.81
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 7 Day 15
|
-0.51 score on a scale
Standard Deviation 30.50
|
-1.27 score on a scale
Standard Deviation 26.60
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 8 Day 15
|
-6.12 score on a scale
Standard Deviation 27.65
|
-1.20 score on a scale
Standard Deviation 27.31
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 9 Day 15
|
-5.16 score on a scale
Standard Deviation 31.26
|
-2.33 score on a scale
Standard Deviation 28.53
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 10 Day 15
|
-4.58 score on a scale
Standard Deviation 30.35
|
-0.81 score on a scale
Standard Deviation 24.55
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 11 Day 15
|
-0.98 score on a scale
Standard Deviation 26.99
|
2.03 score on a scale
Standard Deviation 27.89
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 12 Day 15
|
-3.27 score on a scale
Standard Deviation 26.04
|
-1.54 score on a scale
Standard Deviation 27.28
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 13 Day 15
|
-7.41 score on a scale
Standard Deviation 25.51
|
-5.17 score on a scale
Standard Deviation 27.78
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 14 Day 15
|
-3.88 score on a scale
Standard Deviation 26.44
|
-2.67 score on a scale
Standard Deviation 30.00
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 15 Day 15
|
-5.83 score on a scale
Standard Deviation 22.50
|
5.30 score on a scale
Standard Deviation 32.90
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 16 Day 15
|
0.00 score on a scale
Standard Deviation 25.82
|
0.85 score on a scale
Standard Deviation 31.98
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 17 Day 15
|
-2.67 score on a scale
Standard Deviation 30.31
|
-2.22 score on a scale
Standard Deviation 27.59
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 18 Day 15
|
-1.67 score on a scale
Standard Deviation 27.52
|
-3.33 score on a scale
Standard Deviation 26.27
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 19 Day 15
|
5.88 score on a scale
Standard Deviation 26.97
|
-4.55 score on a scale
Standard Deviation 25.81
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 20 Day 15
|
4.76 score on a scale
Standard Deviation 25.68
|
-2.38 score on a scale
Standard Deviation 24.33
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
Cycle 21 Day 15
|
0.00 score on a scale
Standard Deviation 30.86
|
0.00 score on a scale
Standard Deviation 22.22
|
|
Change From Baseline in EORTC QLQ-C30: Insomnia
EOT visit
|
-4.23 score on a scale
Standard Deviation 32.82
|
-5.91 score on a scale
Standard Deviation 31.67
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 8 Day 15
|
-1.83 score on a scale
Standard Deviation 23.93
|
-4.80 score on a scale
Standard Deviation 20.02
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 18 Day 15
|
0.00 score on a scale
Standard Deviation 15.29
|
-5.00 score on a scale
Standard Deviation 22.36
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 2 Day 1
|
1.35 score on a scale
Standard Deviation 20.71
|
-0.18 score on a scale
Standard Deviation 22.67
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 3 Day 15
|
-2.48 score on a scale
Standard Deviation 23.71
|
-4.44 score on a scale
Standard Deviation 18.60
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 4 Day 15
|
-0.39 score on a scale
Standard Deviation 22.64
|
-4.06 score on a scale
Standard Deviation 21.86
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 5 Day 15
|
-0.83 score on a scale
Standard Deviation 24.14
|
-3.41 score on a scale
Standard Deviation 20.64
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 6 Day 15
|
-3.42 score on a scale
Standard Deviation 23.07
|
-6.44 score on a scale
Standard Deviation 22.67
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 7 Day 15
|
-1.79 score on a scale
Standard Deviation 21.29
|
-5.60 score on a scale
Standard Deviation 20.74
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 9 Day 15
|
-1.98 score on a scale
Standard Deviation 21.55
|
-3.33 score on a scale
Standard Deviation 28.62
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 10 Day 15
|
-1.67 score on a scale
Standard Deviation 23.66
|
-3.66 score on a scale
Standard Deviation 20.96
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 11 Day 15
|
-1.47 score on a scale
Standard Deviation 24.73
|
-1.22 score on a scale
Standard Deviation 26.94
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 12 Day 15
|
-1.31 score on a scale
Standard Deviation 22.07
|
-3.08 score on a scale
Standard Deviation 27.46
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 13 Day 15
|
-5.19 score on a scale
Standard Deviation 23.52
|
-1.15 score on a scale
Standard Deviation 22.48
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 14 Day 15
|
-3.10 score on a scale
Standard Deviation 22.79
|
-1.33 score on a scale
Standard Deviation 32.96
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 15 Day 15
|
-1.67 score on a scale
Standard Deviation 27.16
|
-3.03 score on a scale
Standard Deviation 25.74
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 16 Day 15
|
-2.15 score on a scale
Standard Deviation 30.95
|
-8.55 score on a scale
Standard Deviation 26.18
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 17 Day 15
|
-2.67 score on a scale
Standard Deviation 27.08
|
-5.56 score on a scale
Standard Deviation 17.69
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 19 Day 15
|
3.92 score on a scale
Standard Deviation 11.07
|
-3.03 score on a scale
Standard Deviation 25.01
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 20 Day 15
|
7.14 score on a scale
Standard Deviation 23.31
|
-4.76 score on a scale
Standard Deviation 22.10
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Cycle 21 Day 15
|
0.00 score on a scale
Standard Deviation 0.00
|
-3.33 score on a scale
Standard Deviation 24.60
|
|
Change From Baseline in EORTC QLQ-C30: Appetite Loss
EOT visit
|
3.76 score on a scale
Standard Deviation 30.63
|
6.99 score on a scale
Standard Deviation 36.78
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 13 Day 15
|
5.93 score on a scale
Standard Deviation 26.86
|
5.75 score on a scale
Standard Deviation 17.81
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 14 Day 15
|
10.08 score on a scale
Standard Deviation 27.73
|
5.33 score on a scale
Standard Deviation 19.47
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 15 Day 15
|
2.50 score on a scale
Standard Deviation 26.57
|
3.03 score on a scale
Standard Deviation 20.10
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 16 Day 15
|
4.30 score on a scale
Standard Deviation 31.90
|
1.71 score on a scale
Standard Deviation 15.20
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 17 Day 15
|
14.67 score on a scale
Standard Deviation 36.11
|
3.33 score on a scale
Standard Deviation 20.25
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 18 Day 15
|
3.33 score on a scale
Standard Deviation 37.31
|
3.33 score on a scale
Standard Deviation 28.41
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 19 Day 15
|
1.96 score on a scale
Standard Deviation 32.21
|
6.06 score on a scale
Standard Deviation 24.42
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 20 Day 15
|
7.14 score on a scale
Standard Deviation 26.73
|
9.52 score on a scale
Standard Deviation 15.63
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 21 Day 15
|
12.50 score on a scale
Standard Deviation 17.25
|
3.33 score on a scale
Standard Deviation 18.92
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
EOT visit
|
1.88 score on a scale
Standard Deviation 27.54
|
-0.54 score on a scale
Standard Deviation 31.65
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 2 Day 1
|
3.89 score on a scale
Standard Deviation 27.80
|
4.76 score on a scale
Standard Deviation 25.63
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 3 Day 15
|
9.52 score on a scale
Standard Deviation 29.00
|
5.86 score on a scale
Standard Deviation 26.79
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 4 Day 15
|
8.04 score on a scale
Standard Deviation 28.68
|
6.41 score on a scale
Standard Deviation 24.57
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 5 Day 15
|
5.59 score on a scale
Standard Deviation 29.16
|
7.23 score on a scale
Standard Deviation 27.97
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 6 Day 15
|
5.71 score on a scale
Standard Deviation 29.13
|
6.90 score on a scale
Standard Deviation 23.54
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 7 Day 15
|
4.62 score on a scale
Standard Deviation 30.15
|
7.12 score on a scale
Standard Deviation 26.80
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 8 Day 15
|
0.92 score on a scale
Standard Deviation 27.39
|
6.91 score on a scale
Standard Deviation 28.11
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 9 Day 15
|
1.98 score on a scale
Standard Deviation 22.17
|
4.67 score on a scale
Standard Deviation 26.39
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 10 Day 15
|
6.25 score on a scale
Standard Deviation 27.61
|
2.44 score on a scale
Standard Deviation 23.88
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 11 Day 15
|
5.39 score on a scale
Standard Deviation 26.77
|
4.07 score on a scale
Standard Deviation 20.55
|
|
Change From Baseline in EORTC QLQ-C30: Constipation
Cycle 12 Day 15
|
1.96 score on a scale
Standard Deviation 27.82
|
3.08 score on a scale
Standard Deviation 17.40
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 2 Day 1
|
-3.38 score on a scale
Standard Deviation 23.81
|
-3.17 score on a scale
Standard Deviation 21.78
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 3 Day 15
|
-5.33 score on a scale
Standard Deviation 23.37
|
-4.65 score on a scale
Standard Deviation 24.11
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 4 Day 15
|
-2.16 score on a scale
Standard Deviation 24.90
|
-4.70 score on a scale
Standard Deviation 19.84
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 5 Day 15
|
-3.11 score on a scale
Standard Deviation 23.51
|
-4.22 score on a scale
Standard Deviation 20.49
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 6 Day 15
|
-3.42 score on a scale
Standard Deviation 24.36
|
-0.92 score on a scale
Standard Deviation 21.13
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 7 Day 15
|
-3.33 score on a scale
Standard Deviation 27.17
|
-2.54 score on a scale
Standard Deviation 20.93
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 8 Day 15
|
-5.50 score on a scale
Standard Deviation 25.06
|
-6.01 score on a scale
Standard Deviation 21.18
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 9 Day 15
|
-4.76 score on a scale
Standard Deviation 26.46
|
-3.67 score on a scale
Standard Deviation 25.02
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 10 Day 15
|
-2.92 score on a scale
Standard Deviation 28.16
|
0.00 score on a scale
Standard Deviation 27.22
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 11 Day 15
|
-6.37 score on a scale
Standard Deviation 25.92
|
-2.85 score on a scale
Standard Deviation 23.54
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 12 Day 15
|
-7.84 score on a scale
Standard Deviation 24.57
|
-6.67 score on a scale
Standard Deviation 22.20
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 13 Day 15
|
-2.22 score on a scale
Standard Deviation 28.78
|
-2.30 score on a scale
Standard Deviation 21.50
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 14 Day 15
|
-5.43 score on a scale
Standard Deviation 25.12
|
-2.00 score on a scale
Standard Deviation 19.53
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 15 Day 15
|
-2.50 score on a scale
Standard Deviation 21.86
|
-3.79 score on a scale
Standard Deviation 22.98
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 16 Day 15
|
-3.23 score on a scale
Standard Deviation 17.96
|
-5.13 score on a scale
Standard Deviation 21.00
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 17 Day 15
|
-1.33 score on a scale
Standard Deviation 15.15
|
-6.67 score on a scale
Standard Deviation 18.36
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 18 Day 15
|
-8.33 score on a scale
Standard Deviation 14.81
|
-5.00 score on a scale
Standard Deviation 22.36
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 19 Day 15
|
5.88 score on a scale
Standard Deviation 24.25
|
-7.58 score on a scale
Standard Deviation 25.05
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 20 Day 15
|
-2.38 score on a scale
Standard Deviation 27.62
|
-2.38 score on a scale
Standard Deviation 27.62
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
Cycle 21 Day 15
|
-8.33 score on a scale
Standard Deviation 15.43
|
-10.00 score on a scale
Standard Deviation 31.62
|
|
Change From Baseline in EORTC QLQ-C30: Diarrhea
EOT visit
|
-3.76 score on a scale
Standard Deviation 24.91
|
-1.08 score on a scale
Standard Deviation 24.86
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of financial difficulties. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=197 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=189 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
EOT visit
|
-2.82 score on a scale
Standard Deviation 36.40
|
1.61 score on a scale
Standard Deviation 22.12
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 2 Day 1
|
-5.08 score on a scale
Standard Deviation 24.45
|
-2.82 score on a scale
Standard Deviation 21.56
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 3 Day 15
|
-4.38 score on a scale
Standard Deviation 28.59
|
-2.63 score on a scale
Standard Deviation 22.69
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 4 Day 15
|
-3.33 score on a scale
Standard Deviation 27.77
|
-1.50 score on a scale
Standard Deviation 22.51
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 5 Day 15
|
-3.73 score on a scale
Standard Deviation 29.81
|
-3.61 score on a scale
Standard Deviation 22.33
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 6 Day 15
|
-3.42 score on a scale
Standard Deviation 31.25
|
-0.92 score on a scale
Standard Deviation 21.13
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 7 Day 15
|
-5.13 score on a scale
Standard Deviation 30.06
|
-2.04 score on a scale
Standard Deviation 23.66
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 8 Day 15
|
-4.59 score on a scale
Standard Deviation 32.86
|
-3.90 score on a scale
Standard Deviation 21.90
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 9 Day 15
|
-5.56 score on a scale
Standard Deviation 29.65
|
-2.67 score on a scale
Standard Deviation 23.06
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 10 Day 15
|
-7.50 score on a scale
Standard Deviation 29.99
|
-5.28 score on a scale
Standard Deviation 22.51
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 11 Day 15
|
-9.80 score on a scale
Standard Deviation 30.51
|
-2.85 score on a scale
Standard Deviation 20.42
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 12 Day 15
|
-3.92 score on a scale
Standard Deviation 32.42
|
-3.59 score on a scale
Standard Deviation 23.66
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 13 Day 15
|
-6.67 score on a scale
Standard Deviation 31.46
|
-5.75 score on a scale
Standard Deviation 23.48
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 14 Day 15
|
-5.43 score on a scale
Standard Deviation 26.16
|
-5.33 score on a scale
Standard Deviation 24.61
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 15 Day 15
|
-7.50 score on a scale
Standard Deviation 29.71
|
-0.76 score on a scale
Standard Deviation 30.06
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 16 Day 15
|
1.08 score on a scale
Standard Deviation 26.50
|
-5.98 score on a scale
Standard Deviation 25.21
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 17 Day 15
|
-10.67 score on a scale
Standard Deviation 31.51
|
-7.78 score on a scale
Standard Deviation 18.94
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 18 Day 15
|
0.00 score on a scale
Standard Deviation 28.61
|
-8.33 score on a scale
Standard Deviation 26.21
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 19 Day 15
|
0.00 score on a scale
Standard Deviation 26.35
|
-6.06 score on a scale
Standard Deviation 24.42
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 20 Day 15
|
11.90 score on a scale
Standard Deviation 24.83
|
-7.14 score on a scale
Standard Deviation 26.73
|
|
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Cycle 21 Day 15
|
-4.17 score on a scale
Standard Deviation 33.03
|
-16.67 score on a scale
Standard Deviation 23.57
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for disease symptoms and a positive change from baseline represents more symptoms, worse QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=190 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=186 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 2 Day 1
|
-5.38 score on a scale
Standard Deviation 15.67
|
-4.63 score on a scale
Standard Deviation 15.79
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 4 Day 15
|
-6.56 score on a scale
Standard Deviation 16.95
|
-5.08 score on a scale
Standard Deviation 13.89
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 3 Day 15
|
-5.92 score on a scale
Standard Deviation 17.82
|
-5.28 score on a scale
Standard Deviation 15.74
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 5 Day 15
|
-8.33 score on a scale
Standard Deviation 17.96
|
-5.59 score on a scale
Standard Deviation 16.55
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 6 Day 15
|
-8.14 score on a scale
Standard Deviation 19.15
|
-6.63 score on a scale
Standard Deviation 15.93
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 7 Day 15
|
-8.21 score on a scale
Standard Deviation 17.87
|
-5.94 score on a scale
Standard Deviation 15.87
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 8 Day 15
|
-7.06 score on a scale
Standard Deviation 19.16
|
-4.75 score on a scale
Standard Deviation 14.21
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 9 Day 15
|
-7.70 score on a scale
Standard Deviation 19.49
|
-6.90 score on a scale
Standard Deviation 16.99
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 10 Day 15
|
-7.76 score on a scale
Standard Deviation 19.00
|
-6.23 score on a scale
Standard Deviation 15.21
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 11 Day 15
|
-9.60 score on a scale
Standard Deviation 19.91
|
-4.81 score on a scale
Standard Deviation 13.82
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 12 Day 15
|
-10.22 score on a scale
Standard Deviation 18.52
|
-4.62 score on a scale
Standard Deviation 18.26
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 13 Day 15
|
-5.43 score on a scale
Standard Deviation 16.79
|
-5.75 score on a scale
Standard Deviation 17.69
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 14 Day 15
|
-6.22 score on a scale
Standard Deviation 16.88
|
-8.11 score on a scale
Standard Deviation 14.69
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 15 Day 15
|
-6.13 score on a scale
Standard Deviation 17.51
|
-4.55 score on a scale
Standard Deviation 16.26
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 16 Day 15
|
-6.85 score on a scale
Standard Deviation 16.42
|
-7.12 score on a scale
Standard Deviation 16.76
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 17 Day 15
|
-6.94 score on a scale
Standard Deviation 19.12
|
-4.63 score on a scale
Standard Deviation 13.69
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 18 Day 15
|
-8.19 score on a scale
Standard Deviation 19.80
|
-1.11 score on a scale
Standard Deviation 11.48
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 19 Day 15
|
-6.94 score on a scale
Standard Deviation 13.38
|
0.00 score on a scale
Standard Deviation 12.36
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 20 Day 15
|
-7.26 score on a scale
Standard Deviation 15.28
|
-1.19 score on a scale
Standard Deviation 13.29
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Cycle 21 Day 15
|
-8.33 score on a scale
Standard Deviation 12.94
|
1.67 score on a scale
Standard Deviation 10.81
|
|
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
EOT visit
|
5.40 score on a scale
Standard Deviation 20.70
|
1.08 score on a scale
Standard Deviation 22.76
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for side effects of treatment and a positive change from baseline represents more side effects, worse QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=190 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=186 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 7 Day 15
|
0.83 score on a scale
Standard Deviation 15.31
|
1.42 score on a scale
Standard Deviation 12.96
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 2 Day 1
|
0.30 score on a scale
Standard Deviation 12.29
|
2.05 score on a scale
Standard Deviation 11.38
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 3 Day 15
|
0.55 score on a scale
Standard Deviation 13.29
|
1.68 score on a scale
Standard Deviation 11.26
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 4 Day 15
|
0.14 score on a scale
Standard Deviation 14.86
|
2.21 score on a scale
Standard Deviation 12.34
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 5 Day 15
|
1.75 score on a scale
Standard Deviation 15.08
|
2.51 score on a scale
Standard Deviation 12.18
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 6 Day 15
|
-0.50 score on a scale
Standard Deviation 13.22
|
1.14 score on a scale
Standard Deviation 13.20
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 8 Day 15
|
0.81 score on a scale
Standard Deviation 15.10
|
1.02 score on a scale
Standard Deviation 13.10
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 9 Day 15
|
0.17 score on a scale
Standard Deviation 14.46
|
1.33 score on a scale
Standard Deviation 13.88
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 10 Day 15
|
0.10 score on a scale
Standard Deviation 14.14
|
3.01 score on a scale
Standard Deviation 12.71
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 11 Day 15
|
0.00 score on a scale
Standard Deviation 15.46
|
2.20 score on a scale
Standard Deviation 14.29
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 12 Day 15
|
-2.27 score on a scale
Standard Deviation 13.41
|
0.59 score on a scale
Standard Deviation 12.19
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 13 Day 15
|
-0.93 score on a scale
Standard Deviation 13.38
|
1.37 score on a scale
Standard Deviation 13.43
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 14 Day 15
|
0.36 score on a scale
Standard Deviation 14.86
|
1.27 score on a scale
Standard Deviation 13.61
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 15 Day 15
|
-0.37 score on a scale
Standard Deviation 12.93
|
2.46 score on a scale
Standard Deviation 12.43
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 16 Day 15
|
-0.32 score on a scale
Standard Deviation 14.67
|
2.77 score on a scale
Standard Deviation 13.08
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 17 Day 15
|
-2.39 score on a scale
Standard Deviation 15.70
|
3.25 score on a scale
Standard Deviation 12.11
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 18 Day 15
|
-1.81 score on a scale
Standard Deviation 13.08
|
1.17 score on a scale
Standard Deviation 12.07
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 19 Day 15
|
2.55 score on a scale
Standard Deviation 12.98
|
3.08 score on a scale
Standard Deviation 15.21
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 20 Day 15
|
4.22 score on a scale
Standard Deviation 21.45
|
4.60 score on a scale
Standard Deviation 16.56
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Cycle 21 Day 15
|
-8.84 score on a scale
Standard Deviation 16.10
|
4.48 score on a scale
Standard Deviation 18.29
|
|
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
EOT visit
|
-0.23 score on a scale
Standard Deviation 13.97
|
2.55 score on a scale
Standard Deviation 13.61
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for future perspectives and a positive change from baseline represents better outcomes, better QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=190 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=186 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 2 Day 1
|
5.15 score on a scale
Standard Deviation 19.72
|
2.75 score on a scale
Standard Deviation 19.17
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 3 Day 15
|
6.38 score on a scale
Standard Deviation 22.14
|
3.96 score on a scale
Standard Deviation 20.68
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 4 Day 15
|
9.65 score on a scale
Standard Deviation 24.14
|
5.41 score on a scale
Standard Deviation 22.33
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 5 Day 15
|
8.44 score on a scale
Standard Deviation 22.27
|
4.44 score on a scale
Standard Deviation 22.72
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 6 Day 15
|
7.99 score on a scale
Standard Deviation 23.59
|
4.67 score on a scale
Standard Deviation 21.74
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 7 Day 15
|
6.92 score on a scale
Standard Deviation 24.56
|
4.96 score on a scale
Standard Deviation 21.92
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 8 Day 15
|
5.40 score on a scale
Standard Deviation 23.06
|
5.81 score on a scale
Standard Deviation 20.04
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 9 Day 15
|
7.50 score on a scale
Standard Deviation 25.15
|
5.84 score on a scale
Standard Deviation 22.69
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 10 Day 15
|
6.41 score on a scale
Standard Deviation 23.79
|
5.15 score on a scale
Standard Deviation 18.41
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 11 Day 15
|
3.70 score on a scale
Standard Deviation 24.76
|
4.47 score on a scale
Standard Deviation 18.55
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 12 Day 15
|
1.11 score on a scale
Standard Deviation 26.20
|
5.47 score on a scale
Standard Deviation 17.14
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 13 Day 15
|
3.28 score on a scale
Standard Deviation 21.51
|
6.13 score on a scale
Standard Deviation 17.92
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 14 Day 15
|
1.06 score on a scale
Standard Deviation 23.26
|
8.22 score on a scale
Standard Deviation 22.20
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 15 Day 15
|
1.99 score on a scale
Standard Deviation 28.14
|
3.28 score on a scale
Standard Deviation 21.38
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 16 Day 15
|
1.48 score on a scale
Standard Deviation 26.54
|
7.41 score on a scale
Standard Deviation 15.99
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 17 Day 15
|
-0.46 score on a scale
Standard Deviation 27.89
|
6.30 score on a scale
Standard Deviation 16.93
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 18 Day 15
|
-1.75 score on a scale
Standard Deviation 28.99
|
5.00 score on a scale
Standard Deviation 15.49
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 19 Day 15
|
-8.33 score on a scale
Standard Deviation 23.48
|
3.03 score on a scale
Standard Deviation 18.84
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 20 Day 15
|
-9.40 score on a scale
Standard Deviation 17.48
|
6.35 score on a scale
Standard Deviation 19.84
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Cycle 21 Day 15
|
-1.39 score on a scale
Standard Deviation 15.07
|
7.78 score on a scale
Standard Deviation 18.92
|
|
Change From Baseline in EORTC QLQ-MY20: Future Perspective
EOT visit
|
-2.66 score on a scale
Standard Deviation 25.30
|
-1.97 score on a scale
Standard Deviation 23.68
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for body image and a positive change from baseline represents better outcomes, better QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=190 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=186 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 2 Day 1
|
2.63 score on a scale
Standard Deviation 26.76
|
3.23 score on a scale
Standard Deviation 25.26
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 3 Day 15
|
1.78 score on a scale
Standard Deviation 23.64
|
1.88 score on a scale
Standard Deviation 26.50
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 4 Day 15
|
4.79 score on a scale
Standard Deviation 25.31
|
0.88 score on a scale
Standard Deviation 24.25
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 5 Day 15
|
2.95 score on a scale
Standard Deviation 25.06
|
-0.61 score on a scale
Standard Deviation 27.17
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 6 Day 15
|
5.94 score on a scale
Standard Deviation 26.75
|
-0.92 score on a scale
Standard Deviation 25.74
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 7 Day 15
|
3.85 score on a scale
Standard Deviation 26.13
|
-2.31 score on a scale
Standard Deviation 28.21
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 8 Day 15
|
3.74 score on a scale
Standard Deviation 24.37
|
-2.70 score on a scale
Standard Deviation 27.39
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 9 Day 15
|
5.62 score on a scale
Standard Deviation 25.41
|
2.02 score on a scale
Standard Deviation 26.00
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 10 Day 15
|
6.41 score on a scale
Standard Deviation 26.89
|
0.81 score on a scale
Standard Deviation 26.70
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 11 Day 15
|
6.06 score on a scale
Standard Deviation 23.32
|
-5.69 score on a scale
Standard Deviation 26.09
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 12 Day 15
|
5.33 score on a scale
Standard Deviation 21.68
|
-2.05 score on a scale
Standard Deviation 26.27
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 13 Day 15
|
5.30 score on a scale
Standard Deviation 23.78
|
-4.02 score on a scale
Standard Deviation 31.27
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 14 Day 15
|
3.17 score on a scale
Standard Deviation 20.57
|
0.00 score on a scale
Standard Deviation 30.12
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 15 Day 15
|
4.27 score on a scale
Standard Deviation 23.17
|
-3.03 score on a scale
Standard Deviation 35.08
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 16 Day 15
|
1.11 score on a scale
Standard Deviation 23.95
|
-2.56 score on a scale
Standard Deviation 35.36
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 17 Day 15
|
-4.17 score on a scale
Standard Deviation 24.70
|
5.56 score on a scale
Standard Deviation 32.85
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 18 Day 15
|
1.75 score on a scale
Standard Deviation 17.48
|
8.33 score on a scale
Standard Deviation 26.21
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 19 Day 15
|
-2.08 score on a scale
Standard Deviation 19.12
|
9.09 score on a scale
Standard Deviation 27.57
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 20 Day 15
|
-10.26 score on a scale
Standard Deviation 31.58
|
7.14 score on a scale
Standard Deviation 29.75
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
Cycle 21 Day 15
|
8.33 score on a scale
Standard Deviation 15.43
|
6.67 score on a scale
Standard Deviation 37.84
|
|
Change From Baseline in EORTC QLQ-MY20: Body Image
EOT visit
|
1.88 score on a scale
Standard Deviation 27.54
|
-3.76 score on a scale
Standard Deviation 30.84
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)Population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
The EQ-5D-5L is a standardized measure of health status that provides a simple, generic measure of health utility, and consists of 2 sections: descriptive and a VAS. The descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The VAS records the respondent's self-rated health on a 20-cm vertical scale ranging from 0: the worst health you can imagine to 100: the best health you can imagine. Change from baseline in VAS is reported here. A higher score in VAS and positive change from baseline represents a better level of QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Outcome measures
| Measure |
Isa-SC + Pd
n=189 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=186 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 2 Day 1
|
-0.39 score on a scale
Standard Deviation 14.58
|
0.99 score on a scale
Standard Deviation 17.62
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 3 Day 15
|
-0.10 score on a scale
Standard Deviation 16.28
|
-0.52 score on a scale
Standard Deviation 17.35
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 4 Day 15
|
-0.24 score on a scale
Standard Deviation 19.36
|
0.75 score on a scale
Standard Deviation 18.66
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 5 Day 15
|
1.03 score on a scale
Standard Deviation 19.20
|
0.09 score on a scale
Standard Deviation 17.78
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 6 Day 15
|
2.39 score on a scale
Standard Deviation 18.17
|
0.50 score on a scale
Standard Deviation 19.54
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 7 Day 15
|
3.02 score on a scale
Standard Deviation 18.01
|
-1.55 score on a scale
Standard Deviation 20.69
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 8 Day 15
|
-0.14 score on a scale
Standard Deviation 18.03
|
0.12 score on a scale
Standard Deviation 17.97
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 9 Day 15
|
0.62 score on a scale
Standard Deviation 16.07
|
0.87 score on a scale
Standard Deviation 19.39
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 10 Day 15
|
2.38 score on a scale
Standard Deviation 15.85
|
2.65 score on a scale
Standard Deviation 15.86
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 11 Day 15
|
-1.66 score on a scale
Standard Deviation 17.53
|
-0.51 score on a scale
Standard Deviation 20.30
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 12 Day 15
|
-0.51 score on a scale
Standard Deviation 17.55
|
1.97 score on a scale
Standard Deviation 20.67
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 13 Day 15
|
3.41 score on a scale
Standard Deviation 15.74
|
2.83 score on a scale
Standard Deviation 18.71
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 14 Day 15
|
-0.83 score on a scale
Standard Deviation 17.36
|
1.58 score on a scale
Standard Deviation 18.62
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 15 Day 15
|
-1.69 score on a scale
Standard Deviation 17.75
|
2.41 score on a scale
Standard Deviation 20.90
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 16 Day 15
|
0.72 score on a scale
Standard Deviation 19.44
|
2.38 score on a scale
Standard Deviation 20.48
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 17 Day 15
|
-0.13 score on a scale
Standard Deviation 17.38
|
2.90 score on a scale
Standard Deviation 18.33
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 18 Day 15
|
0.53 score on a scale
Standard Deviation 23.17
|
3.45 score on a scale
Standard Deviation 15.70
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 19 Day 15
|
-6.00 score on a scale
Standard Deviation 15.16
|
-0.05 score on a scale
Standard Deviation 18.17
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 20 Day 15
|
-2.92 score on a scale
Standard Deviation 21.34
|
-2.14 score on a scale
Standard Deviation 12.24
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Cycle 21 Day 15
|
1.88 score on a scale
Standard Deviation 9.19
|
-5.20 score on a scale
Standard Deviation 24.93
|
|
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
EOT visit
|
-5.17 score on a scale
Standard Deviation 17.11
|
-4.25 score on a scale
Standard Deviation 21.94
|
SECONDARY outcome
Timeframe: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 monthsPopulation: The ITT population included all randomized population. Only participants with at least 1 chromosomal abnormality are included in the analysis.
BM aspirate was collected for fluorescent in situ hybridization for analysis of del\[17p\], t\[4;14\], t\[14;16\]) and 1q21+. ORR was also evaluated based on IRC assessment by disease characteristics. ORR for participants with at least 1 chromosomal abnormality i.e. \[del(17p)\] or \[1q21+ and t(4;14) or t(14;16)\] is presented. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Isa-SC + Pd
n=48 Participants
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-IV + Pd
n=53 Participants
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
ORR Based on at Least 1 Chromosomal Abnormality
|
62.5 percentage of participants
|
60.4 percentage of participants
|
Adverse Events
Isa-IV + Pd
Serious events: 127 serious events
Other events: 241 other events
Deaths: 49 deaths
Isa-SC + Pd
Serious events: 139 serious events
Other events: 234 other events
Deaths: 50 deaths
Serious adverse events
| Measure |
Isa-IV + Pd
n=264 participants at risk
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-SC + Pd
n=263 participants at risk
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Bacteraemia
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Bullous Erysipelas
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Covid-19
|
2.7%
7/264 • Number of events 7 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
2.3%
6/263 • Number of events 6 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Covid-19 Pneumonia
|
2.3%
6/264 • Number of events 6 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
2.3%
6/263 • Number of events 6 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Campylobacter Bacteraemia
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Campylobacter Gastroenteritis
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Cellulitis
|
0.76%
2/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Coronavirus Pneumonia
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Cryptococcal Fungaemia
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Cryptosporidiosis Infection
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Cytomegalovirus Chorioretinitis
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Dengue Fever
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Diarrhoea Infectious
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Disseminated Cryptococcosis
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Erysipelas
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Gastroenteritis
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Gastroenteritis Escherichia Coli
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Gastroenteritis Salmonella
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Gastrointestinal Infection
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Haematological Infection
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Infection
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Infective Exacerbation Of Asthma
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Infective Exacerbation Of Chronic Obstructive Airways Disease
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Influenza
|
1.9%
5/264 • Number of events 5 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Listeria Encephalitis
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Liver Abscess
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Localised Infection
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.76%
2/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
1.1%
3/263 • Number of events 4 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Lower Respiratory Tract Infection Viral
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Ludwig Angina
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Meningitis Cryptococcal
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Meningitis Listeria
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Meningococcal Bacteraemia
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Metapneumovirus Infection
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Metapneumovirus Pneumonia
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Neutropenic Infection
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pertussis
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pneumocystis Jirovecii Pneumonia
|
1.1%
3/264 • Number of events 3 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pneumonia
|
13.6%
36/264 • Number of events 42 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
14.4%
38/263 • Number of events 41 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pneumonia Adenoviral
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pneumonia Cytomegaloviral
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pneumonia Escherichia
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pneumonia Haemophilus
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pneumonia Influenzal
|
1.5%
4/264 • Number of events 4 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
1.1%
3/263 • Number of events 3 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pneumonia Legionella
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pneumonia Parainfluenzae Viral
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
1.1%
3/263 • Number of events 3 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.76%
2/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pneumonia Respiratory Syncytial Viral
|
1.1%
3/264 • Number of events 3 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pneumonia Viral
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Respiratory Syncytial Virus Bronchitis
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.76%
2/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Respiratory Tract Infection Bacterial
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Rhinovirus Infection
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Sepsis
|
0.76%
2/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Septic Shock
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Sinusitis
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.38%
1/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Upper Respiratory Fungal Infection
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.9%
5/264 • Number of events 5 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Urinary Tract Infection
|
0.76%
2/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
1.9%
5/263 • Number of events 7 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Urosepsis
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Wound Infection Staphylococcal
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal Adenoma
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Breast Carcinoma
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leptomeningeal Myelomatosis
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma Cell Leukaemia
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma Cell Myeloma
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of Skin
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
4/264 • Number of events 4 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
1.9%
5/263 • Number of events 5 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.9%
5/264 • Number of events 6 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
3.4%
9/263 • Number of events 9 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
3/264 • Number of events 3 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 3 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Endocrine disorders
Adrenal Disorder
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Endocrine disorders
Hypercalcaemia Of Malignancy
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
1.1%
3/263 • Number of events 3 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 3 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Psychiatric disorders
Confusional State
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Psychiatric disorders
Drug Abuse
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Cluster Headache
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Paraparesis
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Peripheral Sensorimotor Neuropathy
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Posterior Reversible Encephalopathy Syndrome
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Putamen Haemorrhage
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Sciatica
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.76%
2/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Syncope
|
0.38%
1/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Toxic Encephalopathy
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Vocal Cord Paralysis
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Eye disorders
Cataract
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Eye disorders
Cataract Nuclear
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.5%
4/264 • Number of events 4 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
1.1%
3/263 • Number of events 3 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Cardiac disorders
Atrial Flutter
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Cardiac disorders
Cardiac Failure
|
0.76%
2/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Cardiac disorders
Myocardial Infarction
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.38%
1/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.76%
2/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.76%
2/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
1.1%
3/263 • Number of events 3 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Constipation
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
1.1%
3/263 • Number of events 4 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Oesophageal Ulcer Haemorrhage
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Hepatobiliary disorders
Hepatitis Fulminant
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Hepatobiliary disorders
Ischaemic Hepatitis
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Skin and subcutaneous tissue disorders
Scar Pain
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.76%
2/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Musculoskeletal and connective tissue disorders
Haematoma Muscle
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
1.9%
5/264 • Number of events 5 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
1.1%
3/263 • Number of events 3 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.76%
2/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
2.3%
6/263 • Number of events 6 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Renal and urinary disorders
Haematuria
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Renal and urinary disorders
Renal Failure
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
General disorders
Asthenia
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
General disorders
Death
|
0.76%
2/264 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
General disorders
Disease Progression
|
2.3%
6/264 • Number of events 6 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
1.5%
4/263 • Number of events 4 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
General disorders
General Physical Health Deterioration
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
General disorders
Pyrexia
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
1.1%
3/263 • Number of events 3 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
General disorders
Sudden Death
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Investigations
Blood Creatinine Increased
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Investigations
Blood Potassium Decreased
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Investigations
Neutrophil Count Decreased
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Investigations
Platelet Count Decreased
|
3.4%
9/264 • Number of events 9 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
1.5%
4/263 • Number of events 4 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.76%
2/263 • Number of events 2 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
1.1%
3/264 • Number of events 3 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.38%
1/264 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.00%
0/263 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
0.00%
0/264 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
0.38%
1/263 • Number of events 1 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
Other adverse events
| Measure |
Isa-IV + Pd
n=264 participants at risk
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
Isa-SC + Pd
n=263 participants at risk
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
6.4%
17/264 • Number of events 18 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
6.8%
18/263 • Number of events 22 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Covid-19
|
12.5%
33/264 • Number of events 35 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
10.3%
27/263 • Number of events 29 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Influenza
|
1.5%
4/264 • Number of events 4 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
5.7%
15/263 • Number of events 15 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
17/264 • Number of events 22 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
6.1%
16/263 • Number of events 18 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Pneumonia
|
8.7%
23/264 • Number of events 24 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
6.8%
18/263 • Number of events 20 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
22.3%
59/264 • Number of events 91 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
22.8%
60/263 • Number of events 107 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Infections and infestations
Urinary Tract Infection
|
6.4%
17/264 • Number of events 20 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
4.2%
11/263 • Number of events 12 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.3%
80/264 • Number of events 158 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
31.9%
84/263 • Number of events 170 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.1%
16/264 • Number of events 22 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
5.7%
15/263 • Number of events 17 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Psychiatric disorders
Insomnia
|
14.8%
39/264 • Number of events 58 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
14.8%
39/263 • Number of events 44 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Dizziness
|
5.3%
14/264 • Number of events 16 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
7.2%
19/263 • Number of events 21 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Headache
|
5.7%
15/264 • Number of events 19 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
4.6%
12/263 • Number of events 13 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
6.8%
18/264 • Number of events 21 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
7.2%
19/263 • Number of events 20 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Nervous system disorders
Tremor
|
6.4%
17/264 • Number of events 17 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
3.4%
9/263 • Number of events 9 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
22/264 • Number of events 25 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
7.6%
20/263 • Number of events 25 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
14/264 • Number of events 14 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
5.3%
14/263 • Number of events 14 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.3%
6/264 • Number of events 8 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
5.7%
15/263 • Number of events 20 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
33/264 • Number of events 40 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
14.4%
38/263 • Number of events 42 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.1%
53/264 • Number of events 81 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
19.0%
50/263 • Number of events 63 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Gastrointestinal disorders
Nausea
|
8.0%
21/264 • Number of events 27 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
6.8%
18/263 • Number of events 19 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
16/264 • Number of events 17 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
4.6%
12/263 • Number of events 13 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.3%
22/264 • Number of events 24 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
9.5%
25/263 • Number of events 27 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
9.5%
25/264 • Number of events 33 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
6.1%
16/263 • Number of events 18 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
5.3%
14/264 • Number of events 14 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
2.7%
7/263 • Number of events 9 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
General disorders
Asthenia
|
7.6%
20/264 • Number of events 24 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
7.6%
20/263 • Number of events 23 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
General disorders
Fatigue
|
14.0%
37/264 • Number of events 41 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
19.4%
51/263 • Number of events 57 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
General disorders
Influenza Like Illness
|
5.3%
14/264 • Number of events 22 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
4.6%
12/263 • Number of events 17 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
General disorders
Oedema Peripheral
|
11.7%
31/264 • Number of events 35 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
8.4%
22/263 • Number of events 26 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
General disorders
Pyrexia
|
6.4%
17/264 • Number of events 22 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
6.1%
16/263 • Number of events 22 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Investigations
Neutrophil Count Decreased
|
15.5%
41/264 • Number of events 60 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
17.5%
46/263 • Number of events 65 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
23.9%
63/264 • Number of events 67 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
1.9%
5/263 • Number of events 6 • Adverse events and deaths were collected from first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months. Interim results are presented up to PCD of 06-Nov-2024.
Adverse events were collected for safety population. All-cause mortality was collected for the randomized population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER