Trial Outcomes & Findings for A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone (NCT NCT03433001)
NCT ID: NCT03433001
Last Updated: 2023-12-07
Results Overview
PFS was defined as the period from the start of ixazomib, lenalidomide, dexamethasone (IRd) therapy in standard medical care to the time of confirmed progressive disease (PD) or confirmed death (regardless of the cause of death), whichever was earlier. PFS was assessed by International Myeloma Working Group (IMWG) Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase ≥ 0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved free light chain (FLC) levels increase \>10 mg/dl or bone marrow plasma cell ≥ 10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Recruitment status
COMPLETED
Target enrollment
295 participants
Primary outcome timeframe
Up to 36 Months as a maximum
Results posted on
2023-12-07
Participant Flow
Participant s took part in the survey at 101 investigative sites in Japan, from 2 April 2018 to 11 June 2021.
A total of 295 participants were enrolled and received the study treatment in this study.
Participant milestones
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Overall Study
STARTED
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295
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Overall Study
COMPLETED
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66
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Overall Study
NOT COMPLETED
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229
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Reasons for withdrawal
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Overall Study
Lack of Efficacy
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109
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Overall Study
Adverse Event
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69
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Overall Study
Withdrawal by Subject
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10
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Overall Study
Death
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12
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Overall Study
Lost to Follow-up
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4
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Overall Study
Other
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25
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Age, Continuous
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71.9 Years
STANDARD_DEVIATION 8.62 • n=295 Participants
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Sex: Female, Male
Female
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127 Participants
n=295 Participants
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Sex: Female, Male
Male
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168 Participants
n=295 Participants
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Region of Enrollment
Japan
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295 Participants
n=295 Participants
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Hight
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157.2 Centimeters (cm)
STANDARD_DEVIATION 9.70 • n=288 Participants • The number analyzed is the number of participants with data available for analysis.
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Weight
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56.91 Kilograms (kg)
STANDARD_DEVIATION 11.122 • n=277 Participants • The number analyzed is the number of participants with data available for analysis.
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BMI
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22.96 Kilogram (kg)/meter (m)^2]
STANDARD_DEVIATION 3.353 • n=276 Participants • The number analyzed is the number of participants with data available for analysis.
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Body Surface Area
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1.562 m^2
STANDARD_DEVIATION 0.1830 • n=276 Participants • The number analyzed is the number of participants with data available for analysis.
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International Staging System (at Initial Diagnosis)
Stage I
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78 Participants
n=295 Participants
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International Staging System (at Initial Diagnosis)
Stage II
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112 Participants
n=295 Participants
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International Staging System (at Initial Diagnosis)
Stage III
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101 Participants
n=295 Participants
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International Staging System (at Initial Diagnosis)
Missing
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4 Participants
n=295 Participants
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International Staging System (at First Treatment)
Stage I
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130 Participants
n=295 Participants
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International Staging System (at First Treatment)
Stage II
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78 Participants
n=295 Participants
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International Staging System (at First Treatment)
Stage III
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31 Participants
n=295 Participants
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International Staging System (at First Treatment)
Missing
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56 Participants
n=295 Participants
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Eastern Cooperative Oncology Group performance status (ECOG P.S.)
0
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147 Participants
n=295 Participants
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Eastern Cooperative Oncology Group performance status (ECOG P.S.)
1
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90 Participants
n=295 Participants
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Eastern Cooperative Oncology Group performance status (ECOG P.S.)
2
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23 Participants
n=295 Participants
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Eastern Cooperative Oncology Group performance status (ECOG P.S.)
3
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18 Participants
n=295 Participants
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Eastern Cooperative Oncology Group performance status (ECOG P.S.)
4
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5 Participants
n=295 Participants
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Eastern Cooperative Oncology Group performance status (ECOG P.S.)
Missing
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12 Participants
n=295 Participants
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PRIMARY outcome
Timeframe: Up to 36 Months as a maximumPopulation: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
PFS was defined as the period from the start of ixazomib, lenalidomide, dexamethasone (IRd) therapy in standard medical care to the time of confirmed progressive disease (PD) or confirmed death (regardless of the cause of death), whichever was earlier. PFS was assessed by International Myeloma Working Group (IMWG) Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase ≥ 0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved free light chain (FLC) levels increase \>10 mg/dl or bone marrow plasma cell ≥ 10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Progression-Free Survival (PFS)
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4.79 Months
Standard Deviation 3.34
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SECONDARY outcome
Timeframe: 12 months and 24 monthsPopulation: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
PFS rate was defined as the percentage of participants who were alive and have not had disease progression at 12 months and 24 months after the date of start of study treatment. PFS was assessed by IMWG Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase ≥ 0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell ≥ 10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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PFS Rate at 12 Months and 24 Months After the Start of Treatment
Month 12
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57 Percentage of Participants
Interval 51.0 to 63.0
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PFS Rate at 12 Months and 24 Months After the Start of Treatment
Month 24
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41 Percentage of Participants
Interval 35.0 to 47.0
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SECONDARY outcome
Timeframe: Up to 36 months as a maximumPopulation: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
OS is defined as the period from the start of IRd therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed.
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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Overall Survival (OS)
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20.23 Months
Standard Deviation 14.28
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SECONDARY outcome
Timeframe: Up to 36 months as a maximumPopulation: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), very good PR (VGPR) and complete response (CR) assessed with IMWG Criteria after each cycle of treatment. Per IMWG criteria, PR: ≥50% reduction of serum M protein+reduction in 24-hour urinary M protein by ≥90%/ to \<200 mg/24-hour or ≥50% decrease in difference between involved and uninvolved free light chain (FLC) levels/ ≥50% reduction in bone marrow plasma cells, if ≥30% at baseline/ ≥50% reduction in size of soft tissue plasmacytomas. VGPR: serum+urine M-protein detectable by immunofixation but not on electrophoresis/ ≥90% reduction in serum M-protein+urine M-protein level \<100 mg/24-hour. CR: negative immunofixation on serum+urine +disappearance of soft tissue plasmacytomas+\<5% plasma cells in bone marrow.
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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Percentage of Participants Who Achieve or Maintain Any Best Response
CR
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20.0 Percentage of Participants
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Percentage of Participants Who Achieve or Maintain Any Best Response
VGPR
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8.5 Percentage of Participants
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Percentage of Participants Who Achieve or Maintain Any Best Response
PR
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22.0 Percentage of Participants
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SECONDARY outcome
Timeframe: Up to 36 months as a maximumPopulation: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
TTNT will be measured as the period from the start of IRd therapy in standard medical care to the start of next treatment or time when death is confirmed (regardless of the cause of death), whichever is earlier.
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Time to Next Treatment (TTNT)
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5.02 Months
Standard Deviation 4.43
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SECONDARY outcome
Timeframe: Up to 36 months as a maximumPopulation: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
DOT is defined as the treatment duration of IRd therapy.
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Duration of Therapy (DOT)
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353.3 Days
Standard Deviation 320.07
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SECONDARY outcome
Timeframe: 12 months and 24 monthsPopulation: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Percentage of Participants Who Continue to Receive Treatment at 12 Months and 24 Months After Start of Treatment
Month 12
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40.0 Percentage of Participants
Interval 34.4 to 45.8
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Percentage of Participants Who Continue to Receive Treatment at 12 Months and 24 Months After Start of Treatment
Month 24
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21.7 Percentage of Participants
Interval 17.1 to 26.8
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SECONDARY outcome
Timeframe: Up to 36 months as a maximumPopulation: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
ORR is defined as the percentage of participants who achieve a best response of PR or better including stringent complete response (sCR), VGPR and PR assessed with IMWG Criteria, after the start of the study treatment.
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Overall Response Rate (ORR)
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53.9 Percentage of Participants
Interval 48.0 to 59.7
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SECONDARY outcome
Timeframe: Up to 36 months as a maximumPopulation: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
The percentage of participants of CR + VGPR is defined as the rate of participants who achieve a best response of VGPR or better (sCR, CR, or VGPR) according to the IMWG Criteria after the start of the IRd therapy.
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Percentage of Participants Who Achieve VGPR or Better (CR+VGPR)
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31.5 Percentage of Participants
Interval 26.3 to 37.2
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SECONDARY outcome
Timeframe: Baseline and End of Treatment (Up to 37 cycles, each cycle was of 28 days)Population: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all \[best\] to 4=Very Much \[worst\]) and 2 questions (7-point scale where 1=Very poor \[worst\] to 7= Excellent \[best\]). Raw scores of Global Health Status in EORTC QLQ-C30 were linearly transformed to a total score between 0-100 and reported, with a high score indicating better QOL.
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=279 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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Patient-Reported Outcome Health-Related Quality of Life (HRQoL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Global Health Status Score
Baseline
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59.95 Score on a Scale
Standard Deviation 22.472
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Patient-Reported Outcome Health-Related Quality of Life (HRQoL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Global Health Status Score
End of Treatment
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75.00 Score on a Scale
Standard Deviation 11.785
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SECONDARY outcome
Timeframe: Baseline and End of Treatment (Up to 37 cycles, each cycle was of 28 days)Population: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. For the body image scale, higher scores = better body image. Higher score for the disease symptoms scale = higher level of symptomatology.
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=278 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
Disease Symptoms: Baseline
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19.33 Score on a Scale
Standard Deviation 18.949
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Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
Disease Symptoms: End of Treatment
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11.11 Score on a Scale
Standard Deviation 7.857
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Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
Side-Effects of Treatment: Baseline
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17.80 Score on a Scale
Standard Deviation 13.903
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Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
Side-Effects of Treatment: End of Treatment
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16.67 Score on a Scale
Standard Deviation 7.857
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Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
Body Image: Baseline
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28.18 Score on a Scale
Standard Deviation 30.397
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Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
Body Image: End of Treatment
|
16.67 Score on a Scale
Standard Deviation 23.570
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Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
Future Perspective: Baseline
|
42.49 Score on a Scale
Standard Deviation 25.634
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Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
Future Perspective: End of Treatment
|
33.33 Score on a Scale
Standard Deviation 0.000
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SECONDARY outcome
Timeframe: Up to 36 months as a maximumPopulation: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
Rate of MRD will be calculated by the percentage of participants who are MRD-negative.
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=68 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Rate of Minimal Residual Disease (MRD) Negativity in Bone Marrow in Participants Who Achieved CR
10^-4=< - Max
|
26.7 Percentage of Participants
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Rate of Minimal Residual Disease (MRD) Negativity in Bone Marrow in Participants Who Achieved CR
10^-5=< - <10^-4
|
16.7 Percentage of Participants
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Rate of Minimal Residual Disease (MRD) Negativity in Bone Marrow in Participants Who Achieved CR
10^-6=< - <10^-5
|
6.7 Percentage of Participants
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Rate of Minimal Residual Disease (MRD) Negativity in Bone Marrow in Participants Who Achieved CR
Negative
|
50.0 Percentage of Participants
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SECONDARY outcome
Timeframe: Up to 36 months as a maximumPopulation: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
RDI is defined as 100\*(Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals \[dose prescribed at enrollment\* number of prescribed doses per cycle\* the number of treated cycles\].
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Relative Dose Intensity (RDI)
Ixazomib
|
66.49 Percent
Standard Deviation 21.054
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Relative Dose Intensity (RDI)
Lenalidomide
|
44.72 Percent
Standard Deviation 22.815
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Relative Dose Intensity (RDI)
Dexamethasone
|
41.07 Percent
Standard Deviation 26.571
|
SECONDARY outcome
Timeframe: Up to 36 months as a maximumPopulation: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Percentage of Participants With Bone Lesions (Bone Evaluation)
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21.5 Percentage of Participants
Interval 12.3 to 33.5
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SECONDARY outcome
Timeframe: Up to 36 months as a maximumPopulation: Safety Analysis Set: all participants who were enrolled into the study and who receive at least one dose of any drug used in IRd therapy (i.e. ixazomib, lenalidomide, or dexamethasone)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 Participants
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Number of Participants Reporting One or More Treatment-Emergent AEs (TEAEs)
|
249 Participants
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Adverse Events
Ixazomib + Lenalidomide + Dexamethasone
Serious events: 96 serious events
Other events: 225 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 participants at risk
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
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|---|---|
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Infections and infestations
Enterocolitis bacterial
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0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Infection
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Periodontitis
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.68%
2/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.68%
2/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.68%
2/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac failure acute
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
9/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
0.68%
2/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Cardiac death
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Death
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
4.7%
14/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis
|
1.0%
3/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Herpes zoster
|
1.0%
3/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pyelonephritis
|
1.0%
3/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
0.68%
2/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia influenzal
|
0.68%
2/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sepsis
|
0.68%
2/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Appendicitis
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis viral
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cytomegalovirus enterocolitis
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Enteritis infectious
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.0%
3/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.68%
2/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Wound
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Platelet count decreased
|
1.0%
3/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight increased
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count decreased
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
4/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
4/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.68%
2/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
4.4%
13/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Loss of consciousness
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
5/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal disorder
|
0.68%
2/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.68%
2/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.68%
2/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary amyloidosis
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.68%
2/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Shock
|
0.34%
1/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Ixazomib + Lenalidomide + Dexamethasone
n=295 participants at risk
Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.8%
29/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.4%
72/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
6.8%
20/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
5.8%
17/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
16/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
5.1%
15/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
16/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Neutrophil count decreased
|
25.8%
76/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Platelet count decreased
|
25.4%
75/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count decreased
|
23.4%
69/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.9%
38/295 • Up to 36 months as a maximum
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER