Trial Outcomes & Findings for Phase II Study of the BiTE® Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL) (NCT NCT00560794)
NCT ID: NCT00560794
Last Updated: 2015-01-26
Results Overview
MRD Response is defined as: * If Philadelphia Chromosome (Ph) positive (+) or translocation (t) (4;11), response was achieved when Ph or t(4;11) was below detection limit and individual rearrangements of immunoglobulin or T-cell receptor genes are below 10\^-4. * If Ph and t(4;11) negative, response was achieved when individual rearrangements of immunoglobulin or T-cell receptor genes are below 10\^-4.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Within 4 treatment cycles, 24 weeks
Results posted on
2015-01-26
Participant Flow
Participant milestones
| Measure |
Blinatumomab
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
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|---|---|
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Overall Study
STARTED
|
21
|
|
Overall Study
Completed 1 Treatment Cycle
|
20
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Blinatumomab
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
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|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Patient was not Compliant
|
1
|
|
Overall Study
Minimal Residual Disease Relapse
|
1
|
|
Overall Study
Hematological Relapse
|
1
|
|
Overall Study
Received Bone Marrow Transplant
|
6
|
Baseline Characteristics
Phase II Study of the BiTE® Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)
Baseline characteristics by cohort
| Measure |
Blinatumomab
n=20 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
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|---|---|
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Age, Continuous
|
49.8 years
STANDARD_DEVIATION 18.3 • n=39 Participants
|
|
Age, Customized
20-30 years
|
3 participants
n=39 Participants
|
|
Age, Customized
31-40 years
|
5 participants
n=39 Participants
|
|
Age, Customized
41-50 years
|
2 participants
n=39 Participants
|
|
Age, Customized
51-60 years
|
1 participants
n=39 Participants
|
|
Age, Customized
61-70 years
|
7 participants
n=39 Participants
|
|
Age, Customized
> 70 years
|
2 participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
20 participants
n=39 Participants
|
|
Genetic Alterations
bcr/abl translocation above detection limit
|
5 participants
n=39 Participants
|
|
Genetic Alterations
t(4;11) translocation above detection limit
|
2 participants
n=39 Participants
|
|
Genetic Alterations
Rearrangements of Ig / TCR genes only
|
13 participants
n=39 Participants
|
|
Genetic Alterations
Rearrangements of Ig / TCR genes & translocations
|
3 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Within 4 treatment cycles, 24 weeksPopulation: Full analysis set
MRD Response is defined as: * If Philadelphia Chromosome (Ph) positive (+) or translocation (t) (4;11), response was achieved when Ph or t(4;11) was below detection limit and individual rearrangements of immunoglobulin or T-cell receptor genes are below 10\^-4. * If Ph and t(4;11) negative, response was achieved when individual rearrangements of immunoglobulin or T-cell receptor genes are below 10\^-4.
Outcome measures
| Measure |
Blinatumomab
n=20 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
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|---|---|
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Percentage of Participants With a Minimal Residual Disease (MRD) Response Within 4 Cycles of Treatment
|
80.0 percentage of participants
Interval 56.3 to 94.3
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SECONDARY outcome
Timeframe: At the end of each treatment cycle - Weeks 4, 10, 16, and 22.Population: Full analysis set
MRD Response is defined as: * If Philadelphia Chromosome (Ph)+ or t(4;11), response was achieved when Ph or t(4;11) was below detection limit and individual rearrangements of immunoglobulin or T-cell receptor genes are below 10\^-4. * If Ph and t(4;11) negative, response was achieved when individual rearrangements of immunoglobulin or T-cell receptor genes are below 10\^-4.
Outcome measures
| Measure |
Blinatumomab
n=20 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
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|---|---|
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Percentage of Participants With an MRD Response After Each Treatment Cycle
MRD negativity achieved after cycle 1
|
80.0 percentage of participants
Interval 56.3 to 94.3
|
|
Percentage of Participants With an MRD Response After Each Treatment Cycle
MRD negativity achieved after cycle 2
|
80.0 percentage of participants
Interval 56.3 to 94.3
|
|
Percentage of Participants With an MRD Response After Each Treatment Cycle
MRD negativity achieved after cycle 3
|
80.0 percentage of participants
Interval 56.3 to 94.3
|
|
Percentage of Participants With an MRD Response After Each Treatment Cycle
MRD negativity achieved after cycle 4
|
80.0 percentage of participants
Interval 56.3 to 94.3
|
SECONDARY outcome
Timeframe: Up to the data cut-off date of 14 January 2010; maximum duration of follow-up was 564 days.Population: Full analysis set
The time to hematological relapse is defined as the time between start of first infusion of blinatumomab and the first result of hematological relapse. Participants without an event of hematological relapse were censored on their last available date of bone marrow aspiration/biopsy. Hematological relapse is defined as \> 5% leukemia cells in bone marrow. Time to hematological relapse was analyzed using Kaplan-Meier methods.
Outcome measures
| Measure |
Blinatumomab
n=20 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
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|---|---|
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Time to Hematological Relapse
|
NA days
The median time to hematological relapse was not reached due to the low number of events
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SECONDARY outcome
Timeframe: Up to the data cut-off date of 14 January 2010; Median follow-up time was 155 daysPopulation: Full analysis set
Time to MRD progression is defined for participants who do not show MRD response at any time during the study as the time from start of first infusion until the first result of MRD progression or hematological relapse, if no MRD progression was diagnosed before hematological relapse. For participants who showed MRD response during the study the time to MRD progression is defined as the time from the date of the first MRD response to the date of MRD relapse. Participants without an event of MRD progression were censored on the day of their last bone marrow aspiration/biopsy. Participants who received a bone marrow transplant were censored on the last day of bone marrow aspiration/biopsy before transplantation. MRD progression is defined as the increase in the MRD level by 1 log as compared to the baseline level (equal to a 10-fold increase in the number of MRD cells), and had to be confirmed within 6 weeks.
Outcome measures
| Measure |
Blinatumomab
n=20 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
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|---|---|
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Time to MRD Progression
|
221.0 days
Interval 170.0 to
Could not be estimated due to the low number of events
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SECONDARY outcome
Timeframe: Up to the data cut-off date of 14 January 2010; Median follow-up time was 116.5 daysPopulation: Full analysis set
Time to MRD relapse is defined only for participants with an MRD response during the study, defined as the time between the date of the first MRD response and the date of MRD relapse. If a participant experienced hematological relapse without having shown MRD positivity before then the time point of MRD relapse is defined as the time point of hematological relapse. Participants without an event of MRD relapse or hematological relapse were censored on the day of their last available bone marrow aspiration/biopsy. If a participant received a bone marrow transplant the last day of bone marrow aspiration/biopsy before transplantation was used as time point for censoring. MRD relapse is defined as reappearance of bcr/abl, and/or t(4;11) translocation at any detection level, and/or by individual rearrangements of immunoglobulin or T-cell receptor genes ≥10\^-4 for at least 1 individual marker measured by an assay with a sensitivity of minimum 10\^-4 and should be confirmed within 6 weeks.
Outcome measures
| Measure |
Blinatumomab
n=15 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
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|---|---|
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Time to MRD Relapse
|
NA days
Median was not reached during the study due to the low number of events
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SECONDARY outcome
Timeframe: From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.Population: Safety analysis set, including all participants who received ≥ 1 infusion of blinatumomab.
The severity (or intensity) of AEs was evaluated according to the grading scale provided in the Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, or according to the following: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death. The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab. A serious adverse event (SAE) is any untoward medical occurrence or effect that, at any dose results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. In addition, all laboratory abnormalities of grade four severity that occur during or after administration of the investigational drug, any overdose and a pregnancy or fathering were reported as SAEs.
Outcome measures
| Measure |
Blinatumomab
n=21 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
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|---|---|
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Number of Participants With Adverse Events
Any adverse event
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21 participants
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Number of Participants With Adverse Events
Adverse events of at least CTC grade 3
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17 participants
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|
Number of Participants With Adverse Events
Treatment-related adverse events
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21 participants
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Number of Participants With Adverse Events
Related adverse events of at least CTC grade 3
|
13 participants
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|
Number of Participants With Adverse Events
Serious adverse evets
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10 participants
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Number of Participants With Adverse Events
Related serious adverse events
|
9 participants
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Number of Participants With Adverse Events
AEs leading to discontinuation of blinatumomab
|
1 participants
|
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Number of Participants With Adverse Events
AEs leading to death
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0 participants
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SECONDARY outcome
Timeframe: At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion.Population: Participants who received blinatumomab with available pharmacodynamic data.
B-cells were measured by flow cytometry.
Outcome measures
| Measure |
Blinatumomab
n=19 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
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|---|---|
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Change From Screening Value in B-cell Count During Cycle 1
Start of infusion (N=19)
|
0.0181 cells/μL
Standard Deviation 0.0803
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Change From Screening Value in B-cell Count During Cycle 1
45 minutes (N=19)
|
-0.0098 cells/μL
Standard Deviation 0.0402
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Change From Screening Value in B-cell Count During Cycle 1
2 hours (N=18)
|
-0.0361 cells/μL
Standard Deviation 0.0621
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|
Change From Screening Value in B-cell Count During Cycle 1
6 hours (N=19)
|
-0.0435 cells/μL
Standard Deviation 0.0685
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Change From Screening Value in B-cell Count During Cycle 1
12 hours (N=16)
|
-0.0417 cells/μL
Standard Deviation 0.0689
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Change From Screening Value in B-cell Count During Cycle 1
24 hours (N=18)
|
-0.0403 cells/μL
Standard Deviation 0.0700
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Change From Screening Value in B-cell Count During Cycle 1
Day 2 (N=17)
|
-0.0310 cells/μL
Standard Deviation 0.0589
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Change From Screening Value in B-cell Count During Cycle 1
Day 7 (N=18)
|
-0.0462 cells/μL
Standard Deviation 0.0717
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Change From Screening Value in B-cell Count During Cycle 1
Day 14 (N=18)
|
-0.0490 cells/μL
Standard Deviation 0.0745
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Change From Screening Value in B-cell Count During Cycle 1
Day 21 (N=18)
|
-0.0494 cells/μL
Standard Deviation 0.0747
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Change From Screening Value in B-cell Count During Cycle 1
Day 28 (N=17)
|
-0.0392 cells/μL
Standard Deviation 0.0634
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Change From Screening Value in B-cell Count During Cycle 1
Day 35 (N=18)
|
-0.0493 cells/μL
Standard Deviation 0.0748
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SECONDARY outcome
Timeframe: At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion.Population: Participants who received blinatumomab with available pharmacodynamic data.
T-cells were measured by flow cytometry.
Outcome measures
| Measure |
Blinatumomab
n=19 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
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|---|---|
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Change From Screening Value in T-cell Count During Cycle 1
Start of infusion (N=19)
|
-0.0418 cells/μL
Standard Deviation 0.2925
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|
Change From Screening Value in T-cell Count During Cycle 1
45 minutes (N=19)
|
-0.3208 cells/μL
Standard Deviation 0.3137
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|
Change From Screening Value in T-cell Count During Cycle 1
2 hours (N=18)
|
-0.4976 cells/μL
Standard Deviation 0.3454
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|
Change From Screening Value in T-cell Count During Cycle 1
6 hours (N=19)
|
-0.5227 cells/μL
Standard Deviation 0.3432
|
|
Change From Screening Value in T-cell Count During Cycle 1
12 hours (N=16)
|
-0.5390 cells/μL
Standard Deviation 0.3649
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|
Change From Screening Value in T-cell Count During Cycle 1
24 hours (N=18)
|
-0.4780 cells/μL
Standard Deviation 0.3774
|
|
Change From Screening Value in T-cell Count During Cycle 1
Day 2 (N=17)
|
-0.3328 cells/μL
Standard Deviation 0.3704
|
|
Change From Screening Value in T-cell Count During Cycle 1
Day 7 (N=18)
|
0.1231 cells/μL
Standard Deviation 0.3051
|
|
Change From Screening Value in T-cell Count During Cycle 1
Day 14 (N=18)
|
0.1172 cells/μL
Standard Deviation 0.4671
|
|
Change From Screening Value in T-cell Count During Cycle 1
Day 21 (N=18)
|
0.1975 cells/μL
Standard Deviation 0.5596
|
|
Change From Screening Value in T-cell Count During Cycle 1
Day 28 (N=17)
|
0.1687 cells/μL
Standard Deviation 0.3119
|
|
Change From Screening Value in T-cell Count During Cycle 1
Day 35 (N=18)
|
0.2271 cells/μL
Standard Deviation 0.3739
|
SECONDARY outcome
Timeframe: Cycle 1 at pre-dose and at post infusion start at 45 minutes; 2, 6, 12, 24, and 48 hours; 7, 14, 21, and 28 days.Population: Safety analysis set
The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-8, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using fluorescence-activated cell sorter (FACS)-based cytometric bead array (CBA) system.The limit of detection (LOD) for the cytokine determination was 20 pg/mL, the limit of quantification (LOQ) was 125 pg/mL.
Outcome measures
| Measure |
Blinatumomab
n=21 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
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|---|---|
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Serum Cytokine Peak Levels in Cycle 1
IL-2
|
NA pg/mL
Standard Deviation NA
Levels less than the limit of quantitation
|
|
Serum Cytokine Peak Levels in Cycle 1
IL-4
|
NA pg/mL
Standard Deviation NA
Levels less than the limit of detection
|
|
Serum Cytokine Peak Levels in Cycle 1
IL-6
|
693.2 pg/mL
Standard Deviation 1122.9
|
|
Serum Cytokine Peak Levels in Cycle 1
IL-8
|
NA pg/mL
Standard Deviation NA
Levels less than the limit of detection
|
|
Serum Cytokine Peak Levels in Cycle 1
IL-10
|
1135.3 pg/mL
Standard Deviation 1155.6
|
|
Serum Cytokine Peak Levels in Cycle 1
IFN-γ
|
408.5 pg/mL
Standard Deviation 614.3
|
|
Serum Cytokine Peak Levels in Cycle 1
TNF-α
|
NA pg/mL
Standard Deviation NA
Levels less than the limit of quantitation
|
SECONDARY outcome
Timeframe: Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.Population: Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.
The mean serum concentration of blinatumomab during cycle 1. The LOQ of the assay was 100 pg/mL, and the limit of detection (LOD) was 3 pg/mL.
Outcome measures
| Measure |
Blinatumomab
n=19 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
|
|---|---|
|
Serum Blinatumomab Concentration at Steady State
|
696 pg/mL
Standard Deviation 147
|
SECONDARY outcome
Timeframe: Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.Population: Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.
Outcome measures
| Measure |
Blinatumomab
n=18 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
|
|---|---|
|
Area Under the Drug Concentration-time Curve From Time Zero to Infinity
|
481 hr*ng/mL
Standard Deviation 106
|
SECONDARY outcome
Timeframe: Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.Population: Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.
Outcome measures
| Measure |
Blinatumomab
n=18 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
|
|---|---|
|
Apparent Volume of Distribution
|
2.00 L/m²
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.Population: Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.
Outcome measures
| Measure |
Blinatumomab
n=19 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
|
|---|---|
|
Clearance of Blinatumomab
|
0.939 L/hr/m²
Standard Deviation 0.199
|
SECONDARY outcome
Timeframe: Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.Population: Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.
Outcome measures
| Measure |
Blinatumomab
n=18 Participants
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
|
|---|---|
|
Terminal Half-life of Blinatumomab
|
1.47 hours
Standard Deviation 0.53
|
Adverse Events
Blinatumomab
Serious events: 10 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Blinatumomab
n=21 participants at risk
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
4.8%
1/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
28.6%
6/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.8%
1/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Infections and infestations
Bacterial sepsis
|
4.8%
1/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Infections and infestations
Bronchopneumonia
|
4.8%
1/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Infections and infestations
Catheter related infection
|
4.8%
1/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Infections and infestations
Escherichia sepsis
|
4.8%
1/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Medical device complication
|
4.8%
1/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
4.8%
1/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Convulsion
|
4.8%
1/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Epilepsy
|
4.8%
1/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Somnolence
|
4.8%
1/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Syncope
|
4.8%
1/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
Other adverse events
| Measure |
Blinatumomab
n=21 participants at risk
Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
7/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
23.8%
5/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.6%
6/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Cardiac disorders
Bradycardia
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Cardiac disorders
Tachycardia
|
19.0%
4/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Eye disorders
Lacrimation increased
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Constipation
|
19.0%
4/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.8%
5/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Dry mouth
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Nausea
|
23.8%
5/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
3/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
General disorders
Catheter site erythema
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
General disorders
Catheter site pain
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
General disorders
Chills
|
42.9%
9/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
General disorders
Fatigue
|
38.1%
8/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
General disorders
Oedema peripheral
|
38.1%
8/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
General disorders
Pyrexia
|
100.0%
21/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Immune system disorders
Immunodeficiency
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Infections and infestations
Bronchitis
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Infections and infestations
Cystitis
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
7/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Infections and infestations
Oral herpes
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Infections and infestations
Pharyngitis
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Infections and infestations
Sinusitis
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
Alanine aminotransferase increased
|
19.0%
4/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
Blood immunoglobulin A decreased
|
66.7%
14/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
Blood immunoglobulin G decreased
|
61.9%
13/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
Blood immunoglobulin M decreased
|
47.6%
10/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
Blood lactate dehydrogenase increased
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
Blood potassium decreased
|
14.3%
3/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
C-reactive protein increased
|
28.6%
6/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
Coagulation factor XIII level increased
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
Fibrin D dimer increased
|
19.0%
4/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
Gamma-glutamyltransferase increased
|
23.8%
5/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
Immunoglobulins decreased
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
Monocyte count increased
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
Weight decreased
|
19.0%
4/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Investigations
Weight increased
|
33.3%
7/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Anorexia
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
19.0%
4/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
47.6%
10/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
6/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
23.8%
5/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Dizziness
|
23.8%
5/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Headache
|
47.6%
10/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Tremor
|
23.8%
5/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Psychiatric disorders
Insomnia
|
23.8%
5/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Renal and urinary disorders
Haematuria
|
23.8%
5/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
3/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.8%
5/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
14.3%
3/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
19.0%
4/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.8%
5/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Vascular disorders
Hypertension
|
9.5%
2/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
|
Vascular disorders
Hypotension
|
23.8%
5/21 • From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER