Phase 1: Number of Participants With Markedly Abnormal Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs)
Study of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma · Source last updated 2019-03-21
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
Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)
What was measured
Laboratory tests included chemistry, hematology and urinalysis. Abnormal laboratory value was assessed as an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from baseline. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Analysis population: Safety population included all participants who received at least 1 dose of any study drug and reported baseline and at least 1 post-baseline value.
Groups in this outcome
Phase 1: Ixazomib 3 mg
Ixazomib 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).
Phase 1: Ixazomib 3.7 mg
Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 25 cycles (approximately 585 days).
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
Phase 1: Ixazomib 3 mg
7
Phase 1: Ixazomib 3.7 mg
7
Reported measurements
Alanine aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
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
Phase 1: Ixazomib 3 mg
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
2
Not reported
Not reported
Not reported
Not reported
Blood creatinine increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
2
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
0
Not reported
Not reported
Not reported
Not reported
Shift to the left
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
1
Not reported
Not reported
Not reported
Not reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
0
Not reported
Not reported
Not reported
Not reported
Blood bicarbonate decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
0
Not reported
Not reported
Not reported
Not reported
Anaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
0
Not reported
Not reported
Not reported
Not reported
Neutropenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
0
Not reported
Not reported
Not reported
Not reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
1
Not reported
Not reported
Not reported
Not reported
Eosinophilia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
1
Not reported
Not reported
Not reported
Not reported
Hypokalaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
0
Not reported
Not reported
Not reported
Not reported
Hyperkalaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
0
Not reported
Not reported
Not reported
Not reported
Hyperglycaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
4
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
0
Not reported
Not reported
Not reported
Not reported
Hyponatraemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
1
Not reported
Not reported
Not reported
Not reported
Hypomagnesaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
0
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
2
Not reported
Not reported
Not reported
Not reported
Hyperchloraemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
0
Not reported
Not reported
Not reported
Not reported
Iron deficiency anaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Phase 1: Ixazomib 3 mg
1
Not reported
Not reported
Not reported
Not reported
Phase 1: Ixazomib 3.7 mg
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
title
Alanine aminotransferase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
Aspartate aminotransferase increased
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Blood creatinine increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Shift to the left
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Platelet count decreased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Blood bicarbonate decreased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Anaemia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Neutropenia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Thrombocytopenia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Eosinophilia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Hypokalaemia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Hyperkalaemia
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
7
units
Participants
description
Laboratory tests included chemistry, hematology and urinalysis. Abnormal laboratory value was assessed as an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from baseline. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
groups
description
Ixazomib 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).
id
OG000
title
Phase 1: Ixazomib 3 mg
description
Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received in this cohort was 25 cycles (approximately 585 days).
id
OG001
title
Phase 1: Ixazomib 3.7 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population included all participants who received at least 1 dose of any study drug and reported baseline and at least 1 post-baseline value.
reporting Status
POSTED
time Frame
Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)
title
Phase 1: Number of Participants With Markedly Abnormal Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs)
Triangle