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NCT05405166 · OUTCOME

Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM · Source last updated 2026-09-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15

What was measured

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.

Analysis population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

Groups in this outcome

Isa-IV + Pd

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

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	233
Isa-SC + Pd	227

Reported measurements

Cycle 1 Day 8: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	217
Isa-SC + Pd	222

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	33.2	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	40.1	Not reported	Not reported	Not reported	Not reported

Cycle 1 Day 8: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	217
Isa-SC + Pd	222

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	14.7	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	36.5	Not reported	Not reported	Not reported	Not reported

Cycle 1 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	210
Isa-SC + Pd	206

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	39.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	43.2	Not reported	Not reported	Not reported	Not reported

Cycle 1 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	210
Isa-SC + Pd	206

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	15.2	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	38.3	Not reported	Not reported	Not reported	Not reported

Cycle 1 Day 22: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	212
Isa-SC + Pd	209

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	39.6	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	45.0	Not reported	Not reported	Not reported	Not reported

Cycle 1 Day 22: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	212
Isa-SC + Pd	209

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	13.2	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	32.5	Not reported	Not reported	Not reported	Not reported

Cycle 2 Day 1: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	233
Isa-SC + Pd	227

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	41.2	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	48.9	Not reported	Not reported	Not reported	Not reported

Cycle 2 Day 1: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	233
Isa-SC + Pd	227

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	13.3	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	31.7	Not reported	Not reported	Not reported	Not reported

Cycle 2 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	221
Isa-SC + Pd	211

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	41.2	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	47.9	Not reported	Not reported	Not reported	Not reported

Cycle 2 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	221
Isa-SC + Pd	211

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	14.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	34.1	Not reported	Not reported	Not reported	Not reported

Cycle 3 Day 1: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	218
Isa-SC + Pd	216

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	38.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	44.9	Not reported	Not reported	Not reported	Not reported

Cycle 3 Day 1: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	218
Isa-SC + Pd	216

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	13.8	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	33.3	Not reported	Not reported	Not reported	Not reported

Cycle 4 Day 1: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	212
Isa-SC + Pd	215

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	36.3	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	44.2	Not reported	Not reported	Not reported	Not reported

Cycle 4 Day 1: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	212
Isa-SC + Pd	215

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	16.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	37.7	Not reported	Not reported	Not reported	Not reported

Cycle 5 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	204
Isa-SC + Pd	193

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	38.7	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	46.6	Not reported	Not reported	Not reported	Not reported

Cycle 5 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	204
Isa-SC + Pd	193

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	15.2	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	32.1	Not reported	Not reported	Not reported	Not reported

Cycle 6 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	174
Isa-SC + Pd	172

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	36.2	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	42.4	Not reported	Not reported	Not reported	Not reported

Cycle 6 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	174
Isa-SC + Pd	172

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	13.8	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	40.7	Not reported	Not reported	Not reported	Not reported

Cycle 7 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	173
Isa-SC + Pd	164

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	33.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	42.7	Not reported	Not reported	Not reported	Not reported

Cycle 7 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	173
Isa-SC + Pd	164

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	16.8	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	40.9	Not reported	Not reported	Not reported	Not reported

Cycle 8 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	165
Isa-SC + Pd	162

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	34.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	44.4	Not reported	Not reported	Not reported	Not reported

Cycle 8 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	165
Isa-SC + Pd	162

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	18.8	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	39.5	Not reported	Not reported	Not reported	Not reported

Cycle 9 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	158
Isa-SC + Pd	144

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	33.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	41.7	Not reported	Not reported	Not reported	Not reported

Cycle 9 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	158
Isa-SC + Pd	144

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	20.3	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	37.5	Not reported	Not reported	Not reported	Not reported

Cycle 10 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	150
Isa-SC + Pd	150

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	36.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	40.7	Not reported	Not reported	Not reported	Not reported

Cycle 10 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	150
Isa-SC + Pd	150

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	19.3	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	46.0	Not reported	Not reported	Not reported	Not reported

Cycle 11 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	150
Isa-SC + Pd	141

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	32.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	39.0	Not reported	Not reported	Not reported	Not reported

Cycle 11 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	150
Isa-SC + Pd	141

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	19.3	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	44.7	Not reported	Not reported	Not reported	Not reported

Cycle 12 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	131
Isa-SC + Pd	135

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	30.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	42.2	Not reported	Not reported	Not reported	Not reported

Cycle 12 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	131
Isa-SC + Pd	135

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	21.4	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	42.2	Not reported	Not reported	Not reported	Not reported

Cycle 13 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	125
Isa-SC + Pd	123

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	33.6	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	46.3	Not reported	Not reported	Not reported	Not reported

Cycle 13 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	125
Isa-SC + Pd	123

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	17.6	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	42.3	Not reported	Not reported	Not reported	Not reported

Cycle 14 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	123
Isa-SC + Pd	125

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	30.9	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	45.6	Not reported	Not reported	Not reported	Not reported

Cycle 14 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	123
Isa-SC + Pd	125

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	20.3	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	40.0	Not reported	Not reported	Not reported	Not reported

Cycle 15 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	114
Isa-SC + Pd	115

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	28.9	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	36.5	Not reported	Not reported	Not reported	Not reported

Cycle 15 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	114
Isa-SC + Pd	115

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	20.2	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	41.7	Not reported	Not reported	Not reported	Not reported

Cycle 16 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	104
Isa-SC + Pd	108

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	27.9	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	38.9	Not reported	Not reported	Not reported	Not reported

Cycle 16 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	104
Isa-SC + Pd	108

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	20.2	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	47.2	Not reported	Not reported	Not reported	Not reported

Cycle 17 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	94
Isa-SC + Pd	95

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	29.8	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	41.1	Not reported	Not reported	Not reported	Not reported

Cycle 17 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	94
Isa-SC + Pd	95

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	18.1	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	45.3	Not reported	Not reported	Not reported	Not reported

Cycle 18 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	86
Isa-SC + Pd	84

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	37.2	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	39.3	Not reported	Not reported	Not reported	Not reported

Cycle 18 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	86
Isa-SC + Pd	84

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	12.8	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	47.6	Not reported	Not reported	Not reported	Not reported

Cycle 19 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	73
Isa-SC + Pd	71

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	37.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	36.6	Not reported	Not reported	Not reported	Not reported

Cycle 19 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	73
Isa-SC + Pd	71

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	16.4	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	45.1	Not reported	Not reported	Not reported	Not reported

Cycle 20 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	58
Isa-SC + Pd	57

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	37.9	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	43.9	Not reported	Not reported	Not reported	Not reported

Cycle 20 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	58
Isa-SC + Pd	57

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	19.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	45.6	Not reported	Not reported	Not reported	Not reported

Cycle 21 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	55
Isa-SC + Pd	47

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	38.2	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	40.4	Not reported	Not reported	Not reported	Not reported

Cycle 21 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	55
Isa-SC + Pd	47

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	7.3	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	46.8	Not reported	Not reported	Not reported	Not reported

Cycle 22 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	51
Isa-SC + Pd	41

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	29.4	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	43.9	Not reported	Not reported	Not reported	Not reported

Cycle 22 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	51
Isa-SC + Pd	41

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	11.8	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	51.2	Not reported	Not reported	Not reported	Not reported

Cycle 23 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	40
Isa-SC + Pd	36

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	32.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	36.1	Not reported	Not reported	Not reported	Not reported

Cycle 23 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	40
Isa-SC + Pd	36

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	7.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	52.8	Not reported	Not reported	Not reported	Not reported

Cycle 24 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	41
Isa-SC + Pd	31

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	22.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	38.7	Not reported	Not reported	Not reported	Not reported

Cycle 24 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	41
Isa-SC + Pd	31

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	17.1	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	48.4	Not reported	Not reported	Not reported	Not reported

Cycle 25 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	35
Isa-SC + Pd	26

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	20.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	46.2	Not reported	Not reported	Not reported	Not reported

Cycle 25 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	35
Isa-SC + Pd	26

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	17.1	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	50.0	Not reported	Not reported	Not reported	Not reported

Cycle 26 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	28
Isa-SC + Pd	25

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	25.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	48.0	Not reported	Not reported	Not reported	Not reported

Cycle 26 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	28
Isa-SC + Pd	25

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	14.3	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	52.0	Not reported	Not reported	Not reported	Not reported

Cycle 27 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	23
Isa-SC + Pd	15

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	21.7	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	40.0	Not reported	Not reported	Not reported	Not reported

Cycle 27 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	23
Isa-SC + Pd	15

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	17.4	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	46.7	Not reported	Not reported	Not reported	Not reported

Cycle 28 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	16
Isa-SC + Pd	14

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	31.3	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	50.0	Not reported	Not reported	Not reported	Not reported

Cycle 28 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	16
Isa-SC + Pd	14

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	25.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	50.0	Not reported	Not reported	Not reported	Not reported

Cycle 29 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	16
Isa-SC + Pd	13

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	25.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	53.8	Not reported	Not reported	Not reported	Not reported

Cycle 29 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	16
Isa-SC + Pd	13

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	25.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	46.2	Not reported	Not reported	Not reported	Not reported

Cycle 30 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	14
Isa-SC + Pd	9

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	28.6	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	55.6	Not reported	Not reported	Not reported	Not reported

Cycle 30 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	14
Isa-SC + Pd	9

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	28.6	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	44.4	Not reported	Not reported	Not reported	Not reported

Cycle 31 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	9
Isa-SC + Pd	6

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	55.6	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	50.0	Not reported	Not reported	Not reported	Not reported

Cycle 31 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	9
Isa-SC + Pd	6

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	11.1	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	50.0	Not reported	Not reported	Not reported	Not reported

Cycle 32 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	8
Isa-SC + Pd	4

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	37.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	75.0	Not reported	Not reported	Not reported	Not reported

Cycle 32 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	8
Isa-SC + Pd	4

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	12.5	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	25.0	Not reported	Not reported	Not reported	Not reported

Cycle 33 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	6
Isa-SC + Pd	6

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	50.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	50.0	Not reported	Not reported	Not reported	Not reported

Cycle 33 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	6
Isa-SC + Pd	6

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	16.7	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	50.0	Not reported	Not reported	Not reported	Not reported

Cycle 34 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	4
Isa-SC + Pd	4

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	75.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	75.0	Not reported	Not reported	Not reported	Not reported

Cycle 34 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	4
Isa-SC + Pd	4

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	25.0	Not reported	Not reported	Not reported	Not reported

Cycle 35 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	4
Isa-SC + Pd	3

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	75.0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	100	Not reported	Not reported	Not reported	Not reported

Cycle 35 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	4
Isa-SC + Pd	3

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	0	Not reported	Not reported	Not reported	Not reported

Cycle 36 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	2
Isa-SC + Pd	3

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	100	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	100	Not reported	Not reported	Not reported	Not reported

Cycle 36 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	2
Isa-SC + Pd	3

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	0	Not reported	Not reported	Not reported	Not reported

Cycle 37 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	2
Isa-SC + Pd	2

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	100	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	100	Not reported	Not reported	Not reported	Not reported

Cycle 37 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	2
Isa-SC + Pd	2

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	0	Not reported	Not reported	Not reported	Not reported

Cycle 38 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	1
Isa-SC + Pd	2

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	100	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	100	Not reported	Not reported	Not reported	Not reported

Cycle 38 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	1
Isa-SC + Pd	2

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-IV + Pd	0	Not reported	Not reported	Not reported	Not reported
Isa-SC + Pd	0	Not reported	Not reported	Not reported	Not reported

Cycle 39 Day 15: disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	0
Isa-SC + Pd	1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-SC + Pd	100	Not reported	Not reported	Not reported	Not reported

Cycle 39 Day 15: strongly disagree

Analysis denominator · Participants

Group	Source count
Isa-IV + Pd	0
Isa-SC + Pd	1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Isa-SC + Pd	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
33.2
group Id
OG001
value
40.1
denoms
counts
group Id
OG000
value
217
group Id
OG001
value
222
units
Participants
title
Cycle 1 Day 8: disagree
categories
measurements
group Id
OG000
value
14.7
group Id
OG001
value
36.5
denoms
counts
group Id
OG000
value
217
group Id
OG001
value
222
units
Participants
title
Cycle 1 Day 8: strongly disagree
categories
measurements
group Id
OG000
value
39.0
group Id
OG001
value
43.2
denoms
counts
group Id
OG000
value
210
group Id
OG001
value
206
units
Participants
title
Cycle 1 Day 15: disagree
categories
measurements
group Id
OG000
value
15.2
group Id
OG001
value
38.3
denoms
counts
group Id
OG000
value
210
group Id
OG001
value
206
units
Participants
title
Cycle 1 Day 15: strongly disagree
categories
measurements
group Id
OG000
value
39.6
group Id
OG001
value
45.0
denoms
counts
group Id
OG000
value
212
group Id
OG001
value
209
units
Participants
title
Cycle 1 Day 22: disagree
categories
measurements
group Id
OG000
value
13.2
group Id
OG001
value
32.5
denoms
counts
group Id
OG000
value
212
group Id
OG001
value
209
units
Participants
title
Cycle 1 Day 22: strongly disagree
categories
measurements
group Id
OG000
value
41.2
group Id
OG001
value
48.9
denoms
counts
group Id
OG000
value
233
group Id
OG001
value
227
units
Participants
title
Cycle 2 Day 1: disagree
categories
measurements
group Id
OG000
value
13.3
group Id
OG001
value
31.7
denoms
counts
group Id
OG000
value
233
group Id
OG001
value
227
units
Participants
title
Cycle 2 Day 1: strongly disagree
categories
measurements
group Id
OG000
value
41.2
group Id
OG001
value
47.9
denoms
counts
group Id
OG000
value
221
group Id
OG001
value
211
units
Participants
title
Cycle 2 Day 15: disagree
categories
measurements
group Id
OG000
value
14.5
group Id
OG001
value
34.1
denoms
counts
group Id
OG000
value
221
group Id
OG001
value
211
units
Participants
title
Cycle 2 Day 15: strongly disagree
categories
measurements
group Id
OG000
value
38.5
group Id
OG001
value
44.9
denoms
counts
group Id
OG000
value
218
group Id
OG001
value
216
units
Participants
title
Cycle 3 Day 1: disagree
categories
measurements
group Id
OG000
value
13.8
group Id
OG001
value
33.3
denoms
counts
group Id
OG000
value
218
group Id
OG001
value
216
units
Participants
title
Cycle 3 Day 1: strongly disagree

denoms

counts
group Id
OG000
value
233
group Id
OG001
value
227
units
Participants

description

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.

groups

description
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.
id
OG000
title
Isa-IV + Pd
description
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.
id
OG001
title
Isa-SC + Pd

param Type

NUMBER

population Description

The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.

reporting Status

POSTED

time Frame

Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15

title

Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'

type

SECONDARY

unit Of Measure

percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice