Number of Participants With Abnormal Serum Chemistry and Hematology Laboratory Values Based on Treatment-emergent Adverse Events (TEAEs)
IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2023-07-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the date of randomization through 30 days after the last dose of study drug up to end of study (up to approximately 9 years)
What was measured
The laboratory values assessment included serum chemistry and hematology. The Serum chemistry assessment included blood urea nitrogen (BUN), creatinine, bilirubin (total), urate, lactate dehydrogenase, phosphate, albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), glucose, sodium, potassium, calcium, chloride, carbon dioxide (CO2), magnesium, thyroid stimulating hormone (TSH). Hematology assessment included hemoglobin, hematocrit, platelet (count), leukocytes with differential neutrophils (ANC). Participants with abnormal serum chemistry laboratory values reported as TEAEs are reported. TEAEs were defined as events that occurred after administration of the first dose of any agent in the study drug regimen and through 30 days after the last dose of any agent in the study drug regimen.
Analysis population: Safety population is defined as all participants who receive at least 1 dose of any study drug. Data for safety is summarized as per the duration of exposure to study treatment (exposure up to 18 cycles; exposure ≥19 cycles).
Groups in this outcome
Placebo + LenDex (Exposure Up to 18 Cycles)
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).
Placebo + LenDex (Exposure ≥19 Cycles)
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib placebo matching capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
Ixazomib + LenDex (Exposure ≥19 Cycles)
Participants who were randomly assigned to receive Ixazomib 4.0 mg placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
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
Placebo + LenDex (Exposure Up to 18 Cycles)
160
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
163
Placebo + LenDex (Exposure ≥19 Cycles)
189
Ixazomib + LenDex (Exposure ≥19 Cycles)
191
Reported measurements
Hypokalaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
16
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
33
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
33
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
39
Not reported
Not reported
Not reported
Not reported
Blood creatinine increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
9
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
6
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
12
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
16
Not reported
Not reported
Not reported
Not reported
Hypophosphataemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
9
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
3
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
9
Not reported
Not reported
Not reported
Not reported
Hypomagnesaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
8
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
6
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
11
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
15
Not reported
Not reported
Not reported
Not reported
Hyponatraemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
7
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
10
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
8
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
7
Not reported
Not reported
Not reported
Not reported
Hyperglycaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
4
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
7
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
16
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
6
Not reported
Not reported
Not reported
Not reported
Hypocalcaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
13
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
6
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
12
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
4
Not reported
Not reported
Not reported
Not reported
Hyperkalaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
3
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
7
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
3
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
3
Not reported
Not reported
Not reported
Not reported
Alanine aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
4
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
10
Not reported
Not reported
Not reported
Not reported
Iron deficiency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
7
Not reported
Not reported
Not reported
Not reported
Hypercalcaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
6
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
5
Not reported
Not reported
Not reported
Not reported
Creatinine renal clearance decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
7
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
4
Not reported
Not reported
Not reported
Not reported
Hypoalbuminaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
5
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
3
Not reported
Not reported
Not reported
Not reported
Aspartate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
0
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
3
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
5
Not reported
Not reported
Not reported
Not reported
Hyperuricaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Anaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
57
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
53
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
52
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
58
Not reported
Not reported
Not reported
Not reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
15
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
34
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
14
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
24
Not reported
Not reported
Not reported
Not reported
Neutropenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
36
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
15
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
48
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
39
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
11
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
5
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
13
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
18
Not reported
Not reported
Not reported
Not reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
6
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
6
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
4
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
15
Not reported
Not reported
Not reported
Not reported
Lymphopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
0
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
7
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
4
Not reported
Not reported
Not reported
Not reported
Febrile neutropenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
5
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
7
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Leukopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
3
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
6
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
4
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
2
Not reported
Not reported
Not reported
Not reported
International normalised ratio increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
4
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
0
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
4
Not reported
Not reported
Not reported
Not reported
Pancytopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
3
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Iron deficiency anaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
4
Not reported
Not reported
Not reported
Not reported
White blood cell count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
5
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
3
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo + LenDex (Exposure Up to 18 Cycles)
1
Not reported
Not reported
Not reported
Not reported
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
2
Not reported
Not reported
Not reported
Not reported
Placebo + LenDex (Exposure ≥19 Cycles)
3
Not reported
Not reported
Not reported
Not reported
Ixazomib + LenDex (Exposure ≥19 Cycles)
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
calculate Pct
false
classes
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
33
group Id
OG002
value
33
group Id
OG003
value
39
title
Hypokalaemia
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
6
group Id
OG002
value
12
group Id
OG003
value
16
title
Blood creatinine increased
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
9
group Id
OG002
value
3
group Id
OG003
value
9
title
Hypophosphataemia
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
6
group Id
OG002
value
11
group Id
OG003
value
15
title
Hypomagnesaemia
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
10
group Id
OG002
value
8
group Id
OG003
value
7
title
Hyponatraemia
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
7
group Id
OG002
value
16
group Id
OG003
value
6
title
Hyperglycaemia
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
6
group Id
OG002
value
12
group Id
OG003
value
4
title
Hypocalcaemia
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
7
group Id
OG002
value
3
group Id
OG003
value
3
title
Hyperkalaemia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
4
group Id
OG003
value
10
title
Alanine aminotransferase increased
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
2
group Id
OG003
value
7
title
Iron deficiency
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
5
title
Hypercalcaemia
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
7
group Id
OG003
value
4
title
Creatinine renal clearance decreased
denoms
counts
group Id
OG000
value
160
group Id
OG001
value
163
group Id
OG002
value
189
group Id
OG003
value
191
units
Participants
description
The laboratory values assessment included serum chemistry and hematology. The Serum chemistry assessment included blood urea nitrogen (BUN), creatinine, bilirubin (total), urate, lactate dehydrogenase, phosphate, albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), glucose, sodium, potassium, calcium, chloride, carbon dioxide (CO2), magnesium, thyroid stimulating hormone (TSH). Hematology assessment included hemoglobin, hematocrit, platelet (count), leukocytes with differential neutrophils (ANC). Participants with abnormal serum chemistry laboratory values reported as TEAEs are reported. TEAEs were defined as events that occurred after administration of the first dose of any agent in the study drug regimen and through 30 days after the last dose of any agent in the study drug regimen.
groups
description
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).
id
OG000
title
Placebo + LenDex (Exposure Up to 18 Cycles)
description
Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).
id
OG001
title
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
description
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib placebo matching capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
id
OG002
title
Placebo + LenDex (Exposure ≥19 Cycles)
description
Participants who were randomly assigned to receive Ixazomib 4.0 mg placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
id
OG003
title
Ixazomib + LenDex (Exposure ≥19 Cycles)
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population is defined as all participants who receive at least 1 dose of any study drug. Data for safety is summarized as per the duration of exposure to study treatment (exposure up to 18 cycles; exposure ≥19 cycles).
reporting Status
POSTED
time Frame
From the date of randomization through 30 days after the last dose of study drug up to end of study (up to approximately 9 years)
title
Number of Participants With Abnormal Serum Chemistry and Hematology Laboratory Values Based on Treatment-emergent Adverse Events (TEAEs)
Triangle