Trial Outcomes & Findings for Clinical Study With Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) (NCT NCT01741792)
NCT ID: NCT01741792
Last Updated: 2017-01-06
Results Overview
Overall response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Overall objective response rate (ORR) is the percentage of participants with a best overall response of complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all evidence of disease and partial response is defined as regression of measureable disease and no new sites.
COMPLETED
PHASE2
25 participants
During the first 8 weeks
2017-01-06
Participant Flow
Adults with a diagnosis of diffuse large B-cell lymphoma (DLBCL) which was refractory to first or subsequent treatment or who had a first or later relapse and were not eligible for autologous hematopoietic stem cell transplant (HSCT), or relapsed after autologous HSCT were eligible to enrol. The primary analysis cut-off date was 10 July 2014.
The study was conducted sequentially in 2 stages and 3 cohorts: In Stage 1, Cohort 1 received an escalating dose of 9/28/112 µg/day blinatumomab and Cohort 2 received a constant dose of 112 µg/day for 8 weeks. In Stage 2, the Cohort 3 dose regimen was determined from the outcome of Cohorts 1 and 2.
Participant milestones
| Measure |
Cohort 1: Blinatumomab 9/28/112 µg/d
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 µg/d
Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 µg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
2
|
14
|
|
Overall Study
Efficacy Set
|
7
|
1
|
13
|
|
Overall Study
COMPLETED
|
3
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
12
|
Reasons for withdrawal
| Measure |
Cohort 1: Blinatumomab 9/28/112 µg/d
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 µg/d
Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 µg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Overall Study
Death
|
6
|
1
|
12
|
Baseline Characteristics
Clinical Study With Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Baseline characteristics by cohort
| Measure |
Cohort 1: Blinatumomab 9/28/112 µg/d
n=9 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 µg/d
n=2 Participants
Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 µg/d
n=14 Participants
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.7 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
|
Gender
Female
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Gender
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
9 participants
n=5 Participants
|
2 participants
n=7 Participants
|
14 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Relapsed/refractory Status to Last Prior Treatment
Relapsed
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Relapsed/refractory Status to Last Prior Treatment
Refractory
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
10 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Number of Previous Autologous Hematopoietic Stem Cell Transplants (HSCT)
None
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
10 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Number of Previous Autologous Hematopoietic Stem Cell Transplants (HSCT)
≥ 1
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During the first 8 weeksPopulation: Efficacy Set includes all participants who completed at least 7 days of infusion on the highest intended dose level.
Overall response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Overall objective response rate (ORR) is the percentage of participants with a best overall response of complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all evidence of disease and partial response is defined as regression of measureable disease and no new sites.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=7 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
n=1 Participants
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
n=13 Participants
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Overall Objective Response Rate During Treatment Cycle 1
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
30.8 percentage of participants
Interval 9.1 to 61.4
|
SECONDARY outcome
Timeframe: During the first 8 weeksPopulation: Efficacy set
Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Complete response is defined as the disappearance of all evidence of disease.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=7 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
n=1 Participants
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
n=13 Participants
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Percentage of Participants With a Best Overall Response of Complete Response
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
0 percentage of participants
Interval 0.0 to 97.5
|
15.4 percentage of participants
Interval 1.9 to 45.4
|
SECONDARY outcome
Timeframe: During the first 8 weeksPopulation: Efficacy set
Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Partial response is defined as regression (\<50% decrease in size of masses) of measureable disease and no new sites.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=7 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
n=1 Participants
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
n=13 Participants
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Percentage of Participants With a Best Overall Response of Partial Response
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
15.4 percentage of participants
Interval 1.9 to 45.4
|
SECONDARY outcome
Timeframe: From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.Population: Efficacy set with an overall objective response of CR or PR during the first treatment cycle
The time from documentation of the first assessment of either partial or complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=4 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
n=1 Participants
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
n=4 Participants
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Duration of Objective Response
|
8.7 months
Interval 0.9 to
Could not be estimated due to the low number of events
|
NA months
Could not be estimated due to the low number of events
|
4.0 months
Interval 1.9 to
Could not be estimated due to the low number of events
|
SECONDARY outcome
Timeframe: From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.Population: Efficacy set with a best overall response of CR during the first treatment cycle
The time from documentation of the first assessment of complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=2 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
n=2 Participants
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Duration of Complete Response
|
NA months
Interval 11.6 to
Could not be estimated due to the low number of events
|
—
|
NA months
Interval 5.9 to
Could not be estimated due to the low number of events
|
SECONDARY outcome
Timeframe: From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.Population: Efficacy set with a best overall response of PR during the first treatment cycle
The time from documentation of the first assessment of partial response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=2 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
n=1 Participants
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
n=2 Participants
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Duration of Partial Response
|
3.3 months
Interval 0.9 to 5.8
|
NA months
Could not be estimated due to the low number of events
|
2.0 months
Interval 1.9 to 2.1
|
SECONDARY outcome
Timeframe: From first infusion of blinatumomab until the end of study; median time on follow-up for PFS was 27.0 months.Population: Efficacy set
The time from the date of first blinatumomab infusion until the date of diagnosis of progression of lymphoma, the start date of new anti-tumor treatment (excluding any stem cell transplantation) or date of death, whichever is the earliest. Patients alive who did not have progression or new anti-tumor treatment (excluding any stem cell transplantation) were censored at last date of tumor assessment.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=7 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
n=1 Participants
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
n=13 Participants
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
3.7 months
Interval 0.7 to 14.1
|
NA months
Could not be estimated due to the low number of events
|
1.6 months
Interval 0.6 to 4.6
|
SECONDARY outcome
Timeframe: From the first infusion of blinatumomab until the end of study; median time on follow-up for overall survival was 26.6 months.Population: Efficacy set
The time from the date of first blinatumomab infusion until death as a result of any cause. Patients still alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. For patients who withdrew their informed consent, only information until the date of withdrawal was analyzed.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=7 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
n=1 Participants
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
n=13 Participants
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Overall Survival (OS)
|
20.1 months
Interval 2.3 to
Could not be estimated due to the low number of events
|
NA months
Could not be estimated due to the low number of events
|
3.6 months
Interval 1.5 to 14.8
|
SECONDARY outcome
Timeframe: From the first dose of blinatumomab until up to 30 days after the last dose or until the data cut-off date of 10 July 2014, whichever occurred first; the overall median duration of treatment exposure was 46.8 days.Population: Safety analysis set
Adverse events were evaluated for severity according to the grading scale provided in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. An adverse event or suspected adverse drug reaction was considered "serious" if it resulted in one of the following outcomes: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions; * Was a congenital anomaly or birth defect; * Was a medically important condition. The Investigator used medical judgment to determine whether there was a causal relationship (ie, related \[reasonably possible\] or unrelated \[not reasonably possible\]) between an adverse event and blinatumomab.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=9 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
n=2 Participants
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
n=14 Participants
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
Any adverse event (AE)
|
9 participants
|
2 participants
|
14 participants
|
|
Number of Participants With Adverse Events
AE of Grade ≥ 3
|
9 participants
|
2 participants
|
13 participants
|
|
Number of Participants With Adverse Events
Serious adverse event (SAE)
|
9 participants
|
2 participants
|
12 participants
|
|
Number of Participants With Adverse Events
Fatal adverse events
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Adverse Events
Led to interruption of study drug
|
4 participants
|
1 participants
|
6 participants
|
|
Number of Participants With Adverse Events
Related adverse events
|
9 participants
|
2 participants
|
11 participants
|
|
Number of Participants With Adverse Events
Related AE Grade ≥ 3
|
5 participants
|
2 participants
|
5 participants
|
|
Number of Participants With Adverse Events
Related AE Grade ≥ 4
|
0 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Adverse Events
Serious related adverse events
|
5 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Adverse Events
Related AE led to discontinuation of study drug
|
2 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Adverse Events
Related AE led to interruption of study drug
|
3 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Adverse Events
AE of Grade ≥ 4
|
0 participants
|
2 participants
|
6 participants
|
|
Number of Participants With Adverse Events
Led to discontinuation of study drug
|
3 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Cycle 1: predose; Day 3 and Day 8 (Css for 9 ug/day); Day 15 (Css for 28 ug/day); and Day 29, Day 43 and Day 57 (Css for 112 ug/day)Population: Pharmacokinetic (PK) data set (all participants who received any infusion of blinatumomab and had at least one PK sample collected).
Blinatumomab serum levels were analyzed using a validated cluster of differentiation (CD)69 activation bioassay with a lower limit of quantification (LLOQ) of 50 pg/mL. Steady-state concentration (Css) was based on actual dose received, rather than based on cohort or time or day.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=20 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
n=16 Participants
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
n=12 Participants
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Blinatumomab Steady State Serum Concentration
|
277 pg/mL
Standard Deviation 210
|
565 pg/mL
Standard Deviation 208
|
2800 pg/mL
Standard Deviation 1150
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Leukocyte (white blood cells) counts were analyzed by differential blood count analysis.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Leukocyte Counts
Screening (N = 25)
|
6.376 1000 cells/µL
Standard Deviation 3.284
|
—
|
—
|
|
Leukocyte Counts
Day 1 Prior (N = 24)
|
5.729 1000 cells/µL
Standard Deviation 2.891
|
—
|
—
|
|
Leukocyte Counts
Day 29 (N = 11)
|
3.764 1000 cells/µL
Standard Deviation 2.160
|
—
|
—
|
|
Leukocyte Counts
Day 43 (N = 8)
|
4.950 1000 cells/µL
Standard Deviation 3.819
|
—
|
—
|
|
Leukocyte Counts
End of Infusion (N = 9)
|
4.611 1000 cells/µL
Standard Deviation 2.114
|
—
|
—
|
|
Leukocyte Counts
End of Core Study (N = 6)
|
6.850 1000 cells/µL
Standard Deviation 2.818
|
—
|
—
|
|
Leukocyte Counts
3-Month Follow-up (N = 5)
|
4.820 1000 cells/µL
Standard Deviation 1.616
|
—
|
—
|
|
Leukocyte Counts
6-Month Follow-up (N = 6)
|
5.183 1000 cells/µL
Standard Deviation 1.380
|
—
|
—
|
|
Leukocyte Counts
9-Month Follow-up (N = 4)
|
4.425 1000 cells/µL
Standard Deviation 0.854
|
—
|
—
|
|
Leukocyte Counts
12-Month Follow-up (N = 4)
|
5.700 1000 cells/µL
Standard Deviation 1.424
|
—
|
—
|
|
Leukocyte Counts
15-Month Follow-up (N = 3)
|
4.767 1000 cells/µL
Standard Deviation 0.874
|
—
|
—
|
|
Leukocyte Counts
18-Month Follow-up (N = 3)
|
6.467 1000 cells/µL
Standard Deviation 1.779
|
—
|
—
|
|
Leukocyte Counts
21-Month Follow-up (N = 21)
|
5.450 1000 cells/µL
Standard Deviation 0.495
|
—
|
—
|
|
Leukocyte Counts
24-Month Follow-up (N = 3)
|
4.533 1000 cells/µL
Standard Deviation 1.069
|
—
|
—
|
|
Leukocyte Counts
Day 8 (N = 21)
|
6.819 1000 cells/µL
Standard Deviation 3.201
|
—
|
—
|
|
Leukocyte Counts
Day 15 (N = 16)
|
6.400 1000 cells/µL
Standard Deviation 2.486
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Lymphocyte counts were analyzed by differential blood count analysis.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Lymphocyte Counts
Screening (N = 25)
|
0.779 1000 cells/µL
Standard Deviation 0.425
|
—
|
—
|
|
Lymphocyte Counts
Day 1 Prior (N = 24)
|
0.491 1000 cells/µL
Standard Deviation 0.259
|
—
|
—
|
|
Lymphocyte Counts
Day 8 (N = 21)
|
0.382 1000 cells/µL
Standard Deviation 0.215
|
—
|
—
|
|
Lymphocyte Counts
Day 15 (N = 16)
|
0.277 1000 cells/µL
Standard Deviation 0.165
|
—
|
—
|
|
Lymphocyte Counts
Day 29 (N = 11)
|
0.472 1000 cells/µL
Standard Deviation 0.273
|
—
|
—
|
|
Lymphocyte Counts
Day 43 (N = 8)
|
0.847 1000 cells/µL
Standard Deviation 0.511
|
—
|
—
|
|
Lymphocyte Counts
End of Infusion (N = 9)
|
0.767 1000 cells/µL
Standard Deviation 0.505
|
—
|
—
|
|
Lymphocyte Counts
12-Month Follow-up (N = 4)
|
1.120 1000 cells/µL
Standard Deviation 0.449
|
—
|
—
|
|
Lymphocyte Counts
15-Month Follow-up (N = 3)
|
0.998 1000 cells/µL
Standard Deviation 0.527
|
—
|
—
|
|
Lymphocyte Counts
18-Month Follow-up (N = 3)
|
0.565 1000 cells/µL
Standard Deviation 0.180
|
—
|
—
|
|
Lymphocyte Counts
21-Month Follow-up (N = 21)
|
1.205 1000 cells/µL
Standard Deviation 0.839
|
—
|
—
|
|
Lymphocyte Counts
24-Month Follow-up (N = 3)
|
0.737 1000 cells/µL
Standard Deviation 0.478
|
—
|
—
|
|
Lymphocyte Counts
End of Core Study (N = 6)
|
1.060 1000 cells/µL
Standard Deviation 0.489
|
—
|
—
|
|
Lymphocyte Counts
3-Month Follow-up (N = 5)
|
1.053 1000 cells/µL
Standard Deviation 0.421
|
—
|
—
|
|
Lymphocyte Counts
6-Month Follow-up (N = 6)
|
1.120 1000 cells/µL
Standard Deviation 0.621
|
—
|
—
|
|
Lymphocyte Counts
9-Month Follow-up (N = 4)
|
1.048 1000 cells/µL
Standard Deviation 0.381
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Monocyte Counts
Screening (N = 25)
|
0.638 1000 cells/µL
Standard Deviation 0.415
|
—
|
—
|
|
Monocyte Counts
Day 1 Prior (N = 24)
|
0.300 1000 cells/µL
Standard Deviation 0.565
|
—
|
—
|
|
Monocyte Counts
Day 8 (N = 21)
|
0.202 1000 cells/µL
Standard Deviation 0.386
|
—
|
—
|
|
Monocyte Counts
Day 15 (N = 16)
|
0.188 1000 cells/µL
Standard Deviation 0.317
|
—
|
—
|
|
Monocyte Counts
Day 29 (N = 11)
|
0.318 1000 cells/µL
Standard Deviation 0.185
|
—
|
—
|
|
Monocyte Counts
Day 43 (N = 8)
|
0.646 1000 cells/µL
Standard Deviation 0.375
|
—
|
—
|
|
Monocyte Counts
End of Infusion (N = 9)
|
0.473 1000 cells/µL
Standard Deviation 0.241
|
—
|
—
|
|
Monocyte Counts
End of Core Study (N = 6)
|
0.711 1000 cells/µL
Standard Deviation 0.569
|
—
|
—
|
|
Monocyte Counts
3-Month Follow-up (N = 5)
|
0.585 1000 cells/µL
Standard Deviation 0.280
|
—
|
—
|
|
Monocyte Counts
6-Month Follow-up (N = 6)
|
0.487 1000 cells/µL
Standard Deviation 0.239
|
—
|
—
|
|
Monocyte Counts
9-Month Follow-up (N = 4)
|
0.452 1000 cells/µL
Standard Deviation 0.112
|
—
|
—
|
|
Monocyte Counts
12-Month Follow-up (N = 4)
|
0.469 1000 cells/µL
Standard Deviation 0.061
|
—
|
—
|
|
Monocyte Counts
15-Month Follow-up (N = 3)
|
0.511 1000 cells/µL
Standard Deviation 0.053
|
—
|
—
|
|
Monocyte Counts
18-Month Follow-up (N = 3)
|
0.290 1000 cells/µL
Standard Deviation 0.123
|
—
|
—
|
|
Monocyte Counts
21-Month Follow-up (N = 21)
|
0.516 1000 cells/µL
Standard Deviation 0.008
|
—
|
—
|
|
Monocyte Counts
24-Month Follow-up (N = 3)
|
0.234 1000 cells/µL
Standard Deviation 0.176
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
Granulocyte Count
Screening (N = 25)
|
4.968 1000 cells/µL
Standard Deviation 3.187
|
—
|
—
|
|
Granulocyte Count
Day 1 Prior (N = 24)
|
4.910 1000 cells/µL
Standard Deviation 2.425
|
—
|
—
|
|
Granulocyte Count
Day 8 (N = 21)
|
6.235 1000 cells/µL
Standard Deviation 2.881
|
—
|
—
|
|
Granulocyte Count
Day 15 (N = 16)
|
5.935 1000 cells/µL
Standard Deviation 2.387
|
—
|
—
|
|
Granulocyte Count
Day 29 (N = 11)
|
2.974 1000 cells/µL
Standard Deviation 2.019
|
—
|
—
|
|
Granulocyte Count
Day 43 (N = 8)
|
3.457 1000 cells/µL
Standard Deviation 3.395
|
—
|
—
|
|
Granulocyte Count
End of Infusion (N = 9)
|
3.353 1000 cells/µL
Standard Deviation 2.134
|
—
|
—
|
|
Granulocyte Count
End of Core Study (N = 6)
|
5.080 1000 cells/µL
Standard Deviation 3.012
|
—
|
—
|
|
Granulocyte Count
3-Month Follow-up (N = 5)
|
3.182 1000 cells/µL
Standard Deviation 1.117
|
—
|
—
|
|
Granulocyte Count
6-Month Follow-up (N = 6)
|
3.594 1000 cells/µL
Standard Deviation 0.950
|
—
|
—
|
|
Granulocyte Count
9-Month Follow-up (N = 4)
|
2.925 1000 cells/µL
Standard Deviation 0.675
|
—
|
—
|
|
Granulocyte Count
12-Month Follow-up (N = 4)
|
4.111 1000 cells/µL
Standard Deviation 1.382
|
—
|
—
|
|
Granulocyte Count
15-Month Follow-up (N = 3)
|
3.258 1000 cells/µL
Standard Deviation 0.745
|
—
|
—
|
|
Granulocyte Count
18-Month Follow-up (N = 3)
|
5.612 1000 cells/µL
Standard Deviation 1.713
|
—
|
—
|
|
Granulocyte Count
21-Month Follow-up (N = 21)
|
3.729 1000 cells/µL
Standard Deviation 0.352
|
—
|
—
|
|
Granulocyte Count
24-Month Follow-up (N = 3)
|
3.563 1000 cells/µL
Standard Deviation 0.711
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
CD19+ B-cell counts were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD19+ B-Cell Count
Day 15 (N = 16)
|
0.000 1000 cells/µL
Standard Deviation 0.001
|
—
|
—
|
|
CD19+ B-Cell Count
Day 29 (N = 11)
|
0.000 1000 cells/µL
Standard Deviation 0.000
|
—
|
—
|
|
CD19+ B-Cell Count
Day 43 (N = 8)
|
0.000 1000 cells/µL
Standard Deviation 0.001
|
—
|
—
|
|
CD19+ B-Cell Count
End of Infusion (N = 9)
|
0.001 1000 cells/µL
Standard Deviation 0.001
|
—
|
—
|
|
CD19+ B-Cell Count
End of Core Study (N = 6)
|
0.001 1000 cells/µL
Standard Deviation 0.002
|
—
|
—
|
|
CD19+ B-Cell Count
3-Month Follow-up (N = 5)
|
0.025 1000 cells/µL
Standard Deviation 0.026
|
—
|
—
|
|
CD19+ B-Cell Count
6-Month Follow-up (N = 6)
|
0.029 1000 cells/µL
Standard Deviation 0.043
|
—
|
—
|
|
CD19+ B-Cell Count
9-Month Follow-up (N = 4)
|
0.054 1000 cells/µL
Standard Deviation 0.066
|
—
|
—
|
|
CD19+ B-Cell Count
12-Month Follow-up (N = 4)
|
0.082 1000 cells/µL
Standard Deviation 0.113
|
—
|
—
|
|
CD19+ B-Cell Count
15-Month Follow-up (N = 3)
|
0.094 1000 cells/µL
Standard Deviation 0.118
|
—
|
—
|
|
CD19+ B-Cell Count
18-Month Follow-up (N = 3)
|
0.071 1000 cells/µL
Standard Deviation 0.075
|
—
|
—
|
|
CD19+ B-Cell Count
21-Month Follow-up (N = 21)
|
0.131 1000 cells/µL
Standard Deviation 0.170
|
—
|
—
|
|
CD19+ B-Cell Count
24-Month Follow-up (N = 3)
|
0.108 1000 cells/µL
Standard Deviation 0.120
|
—
|
—
|
|
CD19+ B-Cell Count
Screening (N = 25)
|
0.026 1000 cells/µL
Standard Deviation 0.072
|
—
|
—
|
|
CD19+ B-Cell Count
Day 1 Prior (N = 24)
|
0.029 1000 cells/µL
Standard Deviation 0.085
|
—
|
—
|
|
CD19+ B-Cell Count
Day 8 (N = 21)
|
0.001 1000 cells/µL
Standard Deviation 0.002
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
CD19+ B-cell counts were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
Screening (N = 25)
|
2 percentage of lymphocytes
Standard Deviation 7
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
Day 1 Prior (N = 24)
|
4 percentage of lymphocytes
Standard Deviation 9
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
Day 8 (N = 21)
|
0 percentage of lymphocytes
Standard Deviation 0
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
Day 15 (N = 16)
|
0 percentage of lymphocytes
Standard Deviation 0
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
Day 29 (N = 11)
|
0 percentage of lymphocytes
Standard Deviation 0
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
Day 43 (N = 8)
|
0 percentage of lymphocytes
Standard Deviation 0
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
End of Infusion (N = 9)
|
0 percentage of lymphocytes
Standard Deviation 0
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
End of Core Study (N = 6)
|
0 percentage of lymphocytes
Standard Deviation 0
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
3-Month Follow-up (N = 5)
|
2 percentage of lymphocytes
Standard Deviation 2
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
6-Month Follow-up (N = 6)
|
2 percentage of lymphocytes
Standard Deviation 3
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
9-Month Follow-up (N = 4)
|
5 percentage of lymphocytes
Standard Deviation 5
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
12-Month Follow-up (N = 4)
|
7 percentage of lymphocytes
Standard Deviation 9
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
15-Month Follow-up (N = 3)
|
7 percentage of lymphocytes
Standard Deviation 7
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
18-Month Follow-up (N = 3)
|
11 percentage of lymphocytes
Standard Deviation 9
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
21-Month Follow-up (N = 21)
|
8 percentage of lymphocytes
Standard Deviation 8
|
—
|
—
|
|
CD19+ B-Cells as a Percentage of All Lymphocytes
24-Month Follow-up (N = 3)
|
12 percentage of lymphocytes
Standard Deviation 7
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
CD3+ T-cell counts were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD3+ T-Cell Count
Screening (N = 25)
|
0.578 1000 cells/µL
Standard Deviation 0.355
|
—
|
—
|
|
CD3+ T-Cell Count
Day 8 (N = 21)
|
0.282 1000 cells/µL
Standard Deviation 0.194
|
—
|
—
|
|
CD3+ T-Cell Count
Day 15 (N = 16)
|
0.199 1000 cells/µL
Standard Deviation 0.159
|
—
|
—
|
|
CD3+ T-Cell Count
Day 29 (N = 11)
|
0.348 1000 cells/µL
Standard Deviation 0.231
|
—
|
—
|
|
CD3+ T-Cell Count
Day 43 (N = 8)
|
0.613 1000 cells/µL
Standard Deviation 0.426
|
—
|
—
|
|
CD3+ T-Cell Count
End of Infusion (N = 9)
|
0.543 1000 cells/µL
Standard Deviation 0.421
|
—
|
—
|
|
CD3+ T-Cell Count
Day 1 Prior (N = 24)
|
0.349 1000 cells/µL
Standard Deviation 0.233
|
—
|
—
|
|
CD3+ T-Cell Count
End of Core Study (N = 6)
|
0.825 1000 cells/µL
Standard Deviation 0.431
|
—
|
—
|
|
CD3+ T-Cell Count
3-Month Follow-up (N = 5)
|
0.773 1000 cells/µL
Standard Deviation 0.443
|
—
|
—
|
|
CD3+ T-Cell Count
6-Month Follow-up (N = 6)
|
0.782 1000 cells/µL
Standard Deviation 0.345
|
—
|
—
|
|
CD3+ T-Cell Count
9-Month Follow-up (N = 4)
|
0.671 1000 cells/µL
Standard Deviation 0.184
|
—
|
—
|
|
CD3+ T-Cell Count
12-Month Follow-up (N = 4)
|
0.703 1000 cells/µL
Standard Deviation 0.203
|
—
|
—
|
|
CD3+ T-Cell Count
15-Month Follow-up (N = 3)
|
0.594 1000 cells/µL
Standard Deviation 0.227
|
—
|
—
|
|
CD3+ T-Cell Count
18-Month Follow-up (N = 3)
|
0.298 1000 cells/µL
Standard Deviation 0.049
|
—
|
—
|
|
CD3+ T-Cell Count
21-Month Follow-up (N = 21)
|
0.623 1000 cells/µL
Standard Deviation 0.266
|
—
|
—
|
|
CD3+ T-Cell Count
24-Month Follow-up (N = 3)
|
0.456 1000 cells/µL
Standard Deviation 0.257
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
CD3+ T-cell counts were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
End of Core Study (N = 6)
|
76 percentage of lymphocytes
Standard Deviation 16
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
3-Month Follow-up (N = 5)
|
73 percentage of lymphocytes
Standard Deviation 11
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
6-Month Follow-up (N = 6)
|
66 percentage of lymphocytes
Standard Deviation 21
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
9-Month Follow-up (N = 4)
|
66 percentage of lymphocytes
Standard Deviation 6
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
12-Month Follow-up (N = 4)
|
65 percentage of lymphocytes
Standard Deviation 9
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
15-Month Follow-up (N = 3)
|
61 percentage of lymphocytes
Standard Deviation 7
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
18-Month Follow-up (N = 3)
|
57 percentage of lymphocytes
Standard Deviation 20
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
21-Month Follow-up (N = 21)
|
58 percentage of lymphocytes
Standard Deviation 16
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
24-Month Follow-up (N = 3)
|
63 percentage of lymphocytes
Standard Deviation 8
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
Day 15 (N = 16)
|
67 percentage of lymphocytes
Standard Deviation 19
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
Day 29 (N = 11)
|
73 percentage of lymphocytes
Standard Deviation 15
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
Day 43 (N = 8)
|
71 percentage of lymphocytes
Standard Deviation 13
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
End of Infusion (N = 9)
|
66 percentage of lymphocytes
Standard Deviation 14
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
Screening (N = 25)
|
72 percentage of lymphocytes
Standard Deviation 14
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
Day 1 Prior (N = 24)
|
68 percentage of lymphocytes
Standard Deviation 18
|
—
|
—
|
|
CD3+ T-Cells as a Percentage of All Lymphocytes
Day 8 (N = 21)
|
70 percentage of lymphocytes
Standard Deviation 19
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
CD4+ T-cell counts were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD4+ T-Cell Count
Screening (N = 25)
|
0.254 1000 cells/µL
Standard Deviation 0.160
|
—
|
—
|
|
CD4+ T-Cell Count
Day 1 Prior (N = 24)
|
0.152 1000 cells/µL
Standard Deviation 0.128
|
—
|
—
|
|
CD4+ T-Cell Count
Day 8 (N = 21)
|
0.131 1000 cells/µL
Standard Deviation 0.128
|
—
|
—
|
|
CD4+ T-Cell Count
Day 15 (N = 16)
|
0.085 1000 cells/µL
Standard Deviation 0.084
|
—
|
—
|
|
CD4+ T-Cell Count
Day 29 (N = 11)
|
0.170 1000 cells/µL
Standard Deviation 0.172
|
—
|
—
|
|
CD4+ T-Cell Count
Day 43 (N = 8)
|
0.261 1000 cells/µL
Standard Deviation 0.219
|
—
|
—
|
|
CD4+ T-Cell Count
End of Infusion (N = 9)
|
0.241 1000 cells/µL
Standard Deviation 0.254
|
—
|
—
|
|
CD4+ T-Cell Count
End of Core Study (N = 6)
|
0.375 1000 cells/µL
Standard Deviation 0.251
|
—
|
—
|
|
CD4+ T-Cell Count
3-Month Follow-up (N = 5)
|
0.371 1000 cells/µL
Standard Deviation 0.216
|
—
|
—
|
|
CD4+ T-Cell Count
6-Month Follow-up (N = 6)
|
0.371 1000 cells/µL
Standard Deviation 0.237
|
—
|
—
|
|
CD4+ T-Cell Count
9-Month Follow-up (N = 4)
|
0.309 1000 cells/µL
Standard Deviation 0.184
|
—
|
—
|
|
CD4+ T-Cell Count
12-Month Follow-up (N = 4)
|
0.399 1000 cells/µL
Standard Deviation 0.193
|
—
|
—
|
|
CD4+ T-Cell Count
15-Month Follow-up (N = 3)
|
0.326 1000 cells/µL
Standard Deviation 0.220
|
—
|
—
|
|
CD4+ T-Cell Count
18-Month Follow-up (N = 3)
|
0.178 1000 cells/µL
Standard Deviation 0.042
|
—
|
—
|
|
CD4+ T-Cell Count
21-Month Follow-up (N = 21)
|
0.373 1000 cells/µL
Standard Deviation 0.279
|
—
|
—
|
|
CD4+ T-Cell Count
24-Month Follow-up (N = 3)
|
0.258 1000 cells/µL
Standard Deviation 0.248
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
CD4+ T-cell counts were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
Screening (N = 25)
|
33 percentage of lymphocytes
Standard Deviation 11
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
Day 1 Prior (N = 24)
|
28 percentage of lymphocytes
Standard Deviation 14
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
Day 8 (N = 21)
|
32 percentage of lymphocytes
Standard Deviation 17
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
Day 15 (N = 16)
|
29 percentage of lymphocytes
Standard Deviation 13
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
Day 29 (N = 11)
|
34 percentage of lymphocytes
Standard Deviation 18
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
Day 43 (N = 8)
|
30 percentage of lymphocytes
Standard Deviation 12
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
End of Infusion (N = 9)
|
28 percentage of lymphocytes
Standard Deviation 13
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
End of Core Study (N = 6)
|
32 percentage of lymphocytes
Standard Deviation 15
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
3-Month Follow-up (N = 5)
|
33 percentage of lymphocytes
Standard Deviation 9
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
6-Month Follow-up (N = 6)
|
30 percentage of lymphocytes
Standard Deviation 10
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
9-Month Follow-up (N = 4)
|
31 percentage of lymphocytes
Standard Deviation 13
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
12-Month Follow-up (N = 4)
|
35 percentage of lymphocytes
Standard Deviation 7
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
15-Month Follow-up (N = 3)
|
31 percentage of lymphocytes
Standard Deviation 7
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
18-Month Follow-up (N = 3)
|
32 percentage of lymphocytes
Standard Deviation 6
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
21-Month Follow-up (N = 21)
|
29 percentage of lymphocytes
Standard Deviation 4
|
—
|
—
|
|
CD4+ T-Cells as a Percentage of All Lymphocytes
24-Month Follow-up (N = 3)
|
34 percentage of lymphocytes
Standard Deviation 8
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
CD8+ T-cell counts were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD8+ T-Cell Count
Screening (N = 25)
|
0.298 1000 cells/µL
Standard Deviation 0.256
|
—
|
—
|
|
CD8+ T-Cell Count
Day 1 Prior (N = 24)
|
0.186 1000 cells/µL
Standard Deviation 0.136
|
—
|
—
|
|
CD8+ T-Cell Count
Day 8 (N = 21)
|
0.134 1000 cells/µL
Standard Deviation 0.099
|
—
|
—
|
|
CD8+ T-Cell Count
Day 15 (N = 16)
|
0.102 1000 cells/µL
Standard Deviation 0.095
|
—
|
—
|
|
CD8+ T-Cell Count
Day 29 (N = 11)
|
0.140 1000 cells/µL
Standard Deviation 0.076
|
—
|
—
|
|
CD8+ T-Cell Count
Day 43 (N = 8)
|
0.299 1000 cells/µL
Standard Deviation 0.237
|
—
|
—
|
|
CD8+ T-Cell Count
End of Infusion (N = 9)
|
0.284 1000 cells/µL
Standard Deviation 0.195
|
—
|
—
|
|
CD8+ T-Cell Count
End of Core Study (N = 6)
|
0.438 1000 cells/µL
Standard Deviation 0.284
|
—
|
—
|
|
CD8+ T-Cell Count
3-Month Follow-up (N = 5)
|
0.381 1000 cells/µL
Standard Deviation 0.254
|
—
|
—
|
|
CD8+ T-Cell Count
6-Month Follow-up (N = 6)
|
0.403 1000 cells/µL
Standard Deviation 0.304
|
—
|
—
|
|
CD8+ T-Cell Count
9-Month Follow-up (N = 4)
|
0.225 1000 cells/µL
Standard Deviation 0.039
|
—
|
—
|
|
CD8+ T-Cell Count
12-Month Follow-up (N = 4)
|
0.310 1000 cells/µL
Standard Deviation 0.200
|
—
|
—
|
|
CD8+ T-Cell Count
15-Month Follow-up (N = 3)
|
0.214 1000 cells/µL
Standard Deviation 0.023
|
—
|
—
|
|
CD8+ T-Cell Count
18-Month Follow-up (N = 3)
|
0.105 1000 cells/µL
Standard Deviation 0.057
|
—
|
—
|
|
CD8+ T-Cell Count
21-Month Follow-up (N = 21)
|
0.185 1000 cells/µL
Standard Deviation 0.026
|
—
|
—
|
|
CD8+ T-Cell Count
24-Month Follow-up (N = 3)
|
0.187 1000 cells/µL
Standard Deviation 0.068
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
CD8+ T-cell counts were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
Screening (N = 25)
|
37 percentage of lymphocytes
Standard Deviation 18
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
Day 1 Prior (N = 24)
|
37 percentage of lymphocytes
Standard Deviation 19
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
Day 8 (N = 21)
|
35 percentage of lymphocytes
Standard Deviation 19
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
Day 15 (N = 16)
|
35 percentage of lymphocytes
Standard Deviation 17
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
Day 29 (N = 11)
|
33 percentage of lymphocytes
Standard Deviation 17
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
Day 43 (N = 8)
|
37 percentage of lymphocytes
Standard Deviation 15
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
End of Infusion (N = 9)
|
36 percentage of lymphocytes
Standard Deviation 16
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
End of Core Study (N = 6)
|
43 percentage of lymphocytes
Standard Deviation 23
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
3-Month Follow-up (N = 5)
|
36 percentage of lymphocytes
Standard Deviation 19
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
6-Month Follow-up (N = 6)
|
34 percentage of lymphocytes
Standard Deviation 16
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
9-Month Follow-up (N = 4)
|
25 percentage of lymphocytes
Standard Deviation 11
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
12-Month Follow-up (N = 4)
|
28 percentage of lymphocytes
Standard Deviation 13
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
15-Month Follow-up (N = 3)
|
24 percentage of lymphocytes
Standard Deviation 9
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
18-Month Follow-up (N = 3)
|
21 percentage of lymphocytes
Standard Deviation 13
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
21-Month Follow-up (N = 21)
|
20 percentage of lymphocytes
Standard Deviation 12
|
—
|
—
|
|
CD8+ T-Cells as a Percentage of All Lymphocytes
24-Month Follow-up (N = 3)
|
27 percentage of lymphocytes
Standard Deviation 16
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
CD19+ B-cells and CD3+ T-cell counts were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
Screening (N = 25)
|
0.04 ratio
Standard Deviation 0.15
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
Day 1 Prior (N = 24)
|
0.07 ratio
Standard Deviation 0.24
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
Day 8 (N = 21)
|
0.00 ratio
Standard Deviation 0.01
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
Day 15 (N = 16)
|
0.00 ratio
Standard Deviation 0.00
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
Day 29 (N = 11)
|
0.00 ratio
Standard Deviation 0.00
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
Day 43 (N = 8)
|
0.00 ratio
Standard Deviation 0.00
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
End of Infusion (N = 9)
|
0.00 ratio
Standard Deviation 0.01
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
End of Core Study (N = 6)
|
0.00 ratio
Standard Deviation 0.00
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
3-Month Follow-up (N = 5)
|
0.03 ratio
Standard Deviation 0.03
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
6-Month Follow-up (N = 6)
|
0.04 ratio
Standard Deviation 0.05
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
9-Month Follow-up (N = 4)
|
0.08 ratio
Standard Deviation 0.08
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
12-Month Follow-up (N = 4)
|
0.12 ratio
Standard Deviation 0.15
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
15-Month Follow-up (N = 3)
|
0.13 ratio
Standard Deviation 0.13
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
18-Month Follow-up (N = 3)
|
0.25 ratio
Standard Deviation 0.30
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
21-Month Follow-up (N = 21)
|
0.17 ratio
Standard Deviation 0.20
|
—
|
—
|
|
CD19+ B-Cell to CD3+ T-Cell Ratio
24-Month Follow-up (N = 3)
|
0.19 ratio
Standard Deviation 0.13
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
CD4+ T-cells and CD8+ T-cell counts were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
Screening (N = 25)
|
1.32 ratio
Standard Deviation 1.19
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
Day 1 Prior (N = 24)
|
1.16 ratio
Standard Deviation 1.45
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
Day 8 (N = 21)
|
1.20 ratio
Standard Deviation 0.96
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
Day 15 (N = 16)
|
1.03 ratio
Standard Deviation 0.71
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
Day 29 (N = 11)
|
1.43 ratio
Standard Deviation 1.08
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
End of Core Study (N = 6)
|
1.03 ratio
Standard Deviation 0.80
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
3-Month Follow-up (N = 5)
|
1.18 ratio
Standard Deviation 0.79
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
6-Month Follow-up (N = 6)
|
1.10 ratio
Standard Deviation 0.70
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
9-Month Follow-up (N = 4)
|
1.53 ratio
Standard Deviation 1.25
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
12-Month Follow-up (N = 4)
|
1.70 ratio
Standard Deviation 1.47
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
15-Month Follow-up (N = 3)
|
1.47 ratio
Standard Deviation 0.81
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
18-Month Follow-up (N = 3)
|
2.23 ratio
Standard Deviation 1.70
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
21-Month Follow-up (N = 21)
|
1.85 ratio
Standard Deviation 1.34
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
24-Month Follow-up (N = 3)
|
1.73 ratio
Standard Deviation 1.21
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
Day 43 (N = 8)
|
0.96 ratio
Standard Deviation 0.53
|
—
|
—
|
|
CD4+ T-Cell to CD8+ T-Cell Ratio
End of Infusion (N = 9)
|
1.09 ratio
Standard Deviation 1.00
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD4+ Naive T Cell Count
Screening (N = 25)
|
0.028 1000 cells/µL
Standard Deviation 0.056
|
—
|
—
|
|
CD4+ Naive T Cell Count
Day 1 Prior (N = 24)
|
0.013 1000 cells/µL
Standard Deviation 0.022
|
—
|
—
|
|
CD4+ Naive T Cell Count
Day 8 (N = 21)
|
0.014 1000 cells/µL
Standard Deviation 0.033
|
—
|
—
|
|
CD4+ Naive T Cell Count
Day 15 (N = 16)
|
0.012 1000 cells/µL
Standard Deviation 0.024
|
—
|
—
|
|
CD4+ Naive T Cell Count
6-Month Follow-up (N = 6)
|
0.023 1000 cells/µL
Standard Deviation 0.044
|
—
|
—
|
|
CD4+ Naive T Cell Count
9-Month Follow-up (N = 4)
|
0.053 1000 cells/µL
Standard Deviation 0.090
|
—
|
—
|
|
CD4+ Naive T Cell Count
12-Month Follow-up (N = 4)
|
0.053 1000 cells/µL
Standard Deviation 0.084
|
—
|
—
|
|
CD4+ Naive T Cell Count
15-Month Follow-up (N = 3)
|
0.044 1000 cells/µL
Standard Deviation 0.059
|
—
|
—
|
|
CD4+ Naive T Cell Count
18-Month Follow-up (N = 3)
|
0.035 1000 cells/µL
Standard Deviation 0.041
|
—
|
—
|
|
CD4+ Naive T Cell Count
21-Month Follow-up (N = 21)
|
0.098 1000 cells/µL
Standard Deviation 0.103
|
—
|
—
|
|
CD4+ Naive T Cell Count
24-Month Follow-up (N = 3)
|
0.016 1000 cells/µL
Standard Deviation 0.013
|
—
|
—
|
|
CD4+ Naive T Cell Count
Day 29 (N = 11)
|
0.032 1000 cells/µL
Standard Deviation 0.071
|
—
|
—
|
|
CD4+ Naive T Cell Count
Day 43 (N = 8)
|
0.036 1000 cells/µL
Standard Deviation 0.060
|
—
|
—
|
|
CD4+ Naive T Cell Count
End of Infusion (N = 9)
|
0.037 1000 cells/µL
Standard Deviation 0.088
|
—
|
—
|
|
CD4+ Naive T Cell Count
End of Core Study (N = 6)
|
0.050 1000 cells/µL
Standard Deviation 0.083
|
—
|
—
|
|
CD4+ Naive T Cell Count
3-Month Follow-up (N = 5)
|
0.015 1000 cells/µL
Standard Deviation 0.019
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
Screening (N = 25)
|
8 percentage of CD4+ T-cells
Standard Deviation 9
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
Day 1 Prior (N = 24)
|
7 percentage of CD4+ T-cells
Standard Deviation 7
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
Day 8 (N = 21)
|
7 percentage of CD4+ T-cells
Standard Deviation 7
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
Day 15 (N = 16)
|
10 percentage of CD4+ T-cells
Standard Deviation 9
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
Day 29 (N = 11)
|
9 percentage of CD4+ T-cells
Standard Deviation 11
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
Day 43 (N = 8)
|
10 percentage of CD4+ T-cells
Standard Deviation 10
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
End of Infusion (N = 9)
|
8 percentage of CD4+ T-cells
Standard Deviation 9
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
End of Core Study (N = 6)
|
9 percentage of CD4+ T-cells
Standard Deviation 13
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
3-Month Follow-up (N = 5)
|
4 percentage of CD4+ T-cells
Standard Deviation 3
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
6-Month Follow-up (N = 6)
|
4 percentage of CD4+ T-cells
Standard Deviation 7
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
9-Month Follow-up (N = 4)
|
11 percentage of CD4+ T-cells
Standard Deviation 15
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
12-Month Follow-up (N = 4)
|
12 percentage of CD4+ T-cells
Standard Deviation 14
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
15-Month Follow-up (N = 3)
|
10 percentage of CD4+ T-cells
Standard Deviation 9
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
18-Month Follow-up (N = 3)
|
19 percentage of CD4+ T-cells
Standard Deviation 19
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
21-Month Follow-up (N = 21)
|
23 percentage of CD4+ T-cells
Standard Deviation 9
|
—
|
—
|
|
CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells
24-Month Follow-up (N = 3)
|
8 percentage of CD4+ T-cells
Standard Deviation 10
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD4+ Central Memory T-Cell (TCM) Count
Day 29 (N = 11)
|
0.032 1000 cells/µL
Standard Deviation 0.065
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
Day 43 (N = 8)
|
0.032 1000 cells/µL
Standard Deviation 0.035
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
End of Infusion (N = 9)
|
0.049 1000 cells/µL
Standard Deviation 0.103
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
End of Core Study (N = 6)
|
0.062 1000 cells/µL
Standard Deviation 0.075
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
3-Month Follow-up (N = 5)
|
0.019 1000 cells/µL
Standard Deviation 0.009
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
6-Month Follow-up (N = 6)
|
0.027 1000 cells/µL
Standard Deviation 0.020
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
9-Month Follow-up (N = 4)
|
0.043 1000 cells/µL
Standard Deviation 0.056
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
12-Month Follow-up (N = 4)
|
0.065 1000 cells/µL
Standard Deviation 0.073
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
15-Month Follow-up (N = 3)
|
0.039 1000 cells/µL
Standard Deviation 0.020
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
18-Month Follow-up (N = 3)
|
0.033 1000 cells/µL
Standard Deviation 0.031
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
21-Month Follow-up (N = 21)
|
0.056 1000 cells/µL
Standard Deviation 0.054
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
24-Month Follow-up (N = 3)
|
0.021 1000 cells/µL
Standard Deviation 0.010
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
Screening (N = 25)
|
0.048 1000 cells/µL
Standard Deviation 0.053
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
Day 1 Prior (N = 24)
|
0.029 1000 cells/µL
Standard Deviation 0.034
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
Day 8 (N = 21)
|
0.027 1000 cells/µL
Standard Deviation 0.042
|
—
|
—
|
|
CD4+ Central Memory T-Cell (TCM) Count
Day 15 (N = 16)
|
0.014 1000 cells/µL
Standard Deviation 0.025
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
Day 1 Prior (N = 24)
|
20 percentage of CD4+ T-cells
Standard Deviation 15
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
Day 8 (N = 21)
|
19 percentage of CD4+ T-cells
Standard Deviation 15
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
Day 15 (N = 16)
|
14 percentage of CD4+ T-cells
Standard Deviation 12
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
Day 29 (N = 11)
|
13 percentage of CD4+ T-cells
Standard Deviation 10
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
Day 43 (N = 8)
|
13 percentage of CD4+ T-cells
Standard Deviation 9
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
End of Infusion (N = 9)
|
15 percentage of CD4+ T-cells
Standard Deviation 11
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
End of Core Study (N = 6)
|
14 percentage of CD4+ T-cells
Standard Deviation 11
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
6-Month Follow-up (N = 6)
|
9 percentage of CD4+ T-cells
Standard Deviation 4
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
9-Month Follow-up (N = 4)
|
11 percentage of CD4+ T-cells
Standard Deviation 9
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
Screening (N = 25)
|
18 percentage of CD4+ T-cells
Standard Deviation 12
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
3-Month Follow-up (N = 5)
|
6 percentage of CD4+ T-cells
Standard Deviation 3
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
12-Month Follow-up (N = 4)
|
18 percentage of CD4+ T-cells
Standard Deviation 16
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
15-Month Follow-up (N = 3)
|
13 percentage of CD4+ T-cells
Standard Deviation 6
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
18-Month Follow-up (N = 3)
|
18 percentage of CD4+ T-cells
Standard Deviation 14
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
21-Month Follow-up (N = 21)
|
14 percentage of CD4+ T-cells
Standard Deviation 4
|
—
|
—
|
|
CD4+ TCM Cells as a Percentage of All CD4+ T-Cells
24-Month Follow-up (N = 3)
|
12 percentage of CD4+ T-cells
Standard Deviation 11
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD4+ Effector Memory T-Cell (TEM) Count
Day 15 (N = 16)
|
0.051 1000 cells/µL
Standard Deviation 0.044
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
Day 29 (N = 11)
|
0.097 1000 cells/µL
Standard Deviation 0.059
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
Day 43 (N = 8)
|
0.169 1000 cells/µL
Standard Deviation 0.117
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
End of Infusion (N = 9)
|
0.140 1000 cells/µL
Standard Deviation 0.091
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
End of Core Study (N = 6)
|
0.220 1000 cells/µL
Standard Deviation 0.142
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
Screening (N = 25)
|
0.161 1000 cells/µL
Standard Deviation 0.089
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
Day 1 Prior (N = 24)
|
0.099 1000 cells/µL
Standard Deviation 0.096
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
Day 8 (N = 21)
|
0.083 1000 cells/µL
Standard Deviation 0.076
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
3-Month Follow-up (N = 5)
|
0.279 1000 cells/µL
Standard Deviation 0.153
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
6-Month Follow-up (N = 6)
|
0.267 1000 cells/µL
Standard Deviation 0.158
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
9-Month Follow-up (N = 4)
|
0.191 1000 cells/µL
Standard Deviation 0.037
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
12-Month Follow-up (N = 4)
|
0.226 1000 cells/µL
Standard Deviation 0.100
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
15-Month Follow-up (N = 3)
|
0.199 1000 cells/µL
Standard Deviation 0.087
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
18-Month Follow-up (N = 3)
|
0.106 1000 cells/µL
Standard Deviation 0.066
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
21-Month Follow-up (N = 21)
|
0.181 1000 cells/µL
Standard Deviation 0.107
|
—
|
—
|
|
CD4+ Effector Memory T-Cell (TEM) Count
24-Month Follow-up (N = 3)
|
0.175 1000 cells/µL
Standard Deviation 0.133
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
9-Month Follow-up (N = 4)
|
42 percentage of CD4+ T-cells
Standard Deviation 18
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
12-Month Follow-up (N = 4)
|
40 percentage of CD4+ T-cells
Standard Deviation 15
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
15-Month Follow-up (N = 3)
|
46 percentage of CD4+ T-cells
Standard Deviation 17
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
18-Month Follow-up (N = 3)
|
43 percentage of CD4+ T-cells
Standard Deviation 12
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
21-Month Follow-up (N = 21)
|
45 percentage of CD4+ T-cells
Standard Deviation 3
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
24-Month Follow-up (N = 3)
|
51 percentage of CD4+ T-cells
Standard Deviation 22
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
Screening (N = 25)
|
41 percentage of CD4+ T-cells
Standard Deviation 19
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
Day 1 Prior (N = 24)
|
39 percentage of CD4+ T-cells
Standard Deviation 19
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
Day 8 (N = 21)
|
36 percentage of CD4+ T-cells
Standard Deviation 19
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
Day 15 (N = 16)
|
46 percentage of CD4+ T-cells
Standard Deviation 17
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
Day 29 (N = 11)
|
34 percentage of CD4+ T-cells
Standard Deviation 20
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
Day 43 (N = 8)
|
39 percentage of CD4+ T-cells
Standard Deviation 26
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
End of Infusion (N = 9)
|
41 percentage of CD4+ T-cells
Standard Deviation 24
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
End of Core Study (N = 6)
|
41 percentage of CD4+ T-cells
Standard Deviation 24
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
3-Month Follow-up (N = 5)
|
46 percentage of CD4+ T-cells
Standard Deviation 26
|
—
|
—
|
|
CD4+ TEM Cells as a Percentage of All CD4+ T-Cells
6-Month Follow-up (N = 6)
|
41 percentage of CD4+ T-cells
Standard Deviation 21
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD8+ Naive T-Cell Count
Screening (N = 25)
|
0.029 1000 cells/µL
Standard Deviation 0.043
|
—
|
—
|
|
CD8+ Naive T-Cell Count
Day 1 Prior (N = 24)
|
0.024 1000 cells/µL
Standard Deviation 0.050
|
—
|
—
|
|
CD8+ Naive T-Cell Count
Day 8 (N = 21)
|
0.010 1000 cells/µL
Standard Deviation 0.012
|
—
|
—
|
|
CD8+ Naive T-Cell Count
Day 15 (N = 16)
|
0.006 1000 cells/µL
Standard Deviation 0.005
|
—
|
—
|
|
CD8+ Naive T-Cell Count
Day 29 (N = 11)
|
0.012 1000 cells/µL
Standard Deviation 0.014
|
—
|
—
|
|
CD8+ Naive T-Cell Count
6-Month Follow-up (N = 6)
|
0.020 1000 cells/µL
Standard Deviation 0.022
|
—
|
—
|
|
CD8+ Naive T-Cell Count
9-Month Follow-up (N = 4)
|
0.011 1000 cells/µL
Standard Deviation 0.012
|
—
|
—
|
|
CD8+ Naive T-Cell Count
12-Month Follow-up (N = 4)
|
0.011 1000 cells/µL
Standard Deviation 0.009
|
—
|
—
|
|
CD8+ Naive T-Cell Count
15-Month Follow-up (N = 3)
|
0.014 1000 cells/µL
Standard Deviation 0.011
|
—
|
—
|
|
CD8+ Naive T-Cell Count
18-Month Follow-up (N = 3)
|
0.007 1000 cells/µL
Standard Deviation 0.008
|
—
|
—
|
|
CD8+ Naive T-Cell Count
21-Month Follow-up (N = 21)
|
0.015 1000 cells/µL
Standard Deviation 0.006
|
—
|
—
|
|
CD8+ Naive T-Cell Count
24-Month Follow-up (N = 3)
|
0.010 1000 cells/µL
Standard Deviation 0.009
|
—
|
—
|
|
CD8+ Naive T-Cell Count
Day 43 (N = 8)
|
0.019 1000 cells/µL
Standard Deviation 0.036
|
—
|
—
|
|
CD8+ Naive T-Cell Count
End of Infusion (N = 9)
|
0.011 1000 cells/µL
Standard Deviation 0.015
|
—
|
—
|
|
CD8+ Naive T-Cell Count
End of Core Study (N = 6)
|
0.023 1000 cells/µL
Standard Deviation 0.018
|
—
|
—
|
|
CD8+ Naive T-Cell Count
3-Month Follow-up (N = 5)
|
0.011 1000 cells/µL
Standard Deviation 0.007
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
Screening (N = 25)
|
10 percentage of CD8+ T-cells
Standard Deviation 10
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
Day 1 Prior (N = 24)
|
12 percentage of CD8+ T-cells
Standard Deviation 13
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
Day 8 (N = 21)
|
9 percentage of CD8+ T-cells
Standard Deviation 8
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
Day 15 (N = 16)
|
8 percentage of CD8+ T-cells
Standard Deviation 7
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
Day 29 (N = 11)
|
8 percentage of CD8+ T-cells
Standard Deviation 7
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
Day 43 (N = 8)
|
6 percentage of CD8+ T-cells
Standard Deviation 7
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
End of Infusion (N = 9)
|
3 percentage of CD8+ T-cells
Standard Deviation 3
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
End of Core Study (N = 6)
|
6 percentage of CD8+ T-cells
Standard Deviation 6
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
3-Month Follow-up (N = 5)
|
4 percentage of CD8+ T-cells
Standard Deviation 4
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
6-Month Follow-up (N = 6)
|
5 percentage of CD8+ T-cells
Standard Deviation 5
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
9-Month Follow-up (N = 4)
|
6 percentage of CD8+ T-cells
Standard Deviation 7
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
12-Month Follow-up (N = 4)
|
6 percentage of CD8+ T-cells
Standard Deviation 6
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
15-Month Follow-up (N = 3)
|
6 percentage of CD8+ T-cells
Standard Deviation 5
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
18-Month Follow-up (N = 3)
|
10 percentage of CD8+ T-cells
Standard Deviation 8
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
21-Month Follow-up (N = 21)
|
8 percentage of CD8+ T-cells
Standard Deviation 4
|
—
|
—
|
|
CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells
24-Month Follow-up (N = 3)
|
10 percentage of CD8+ T-cells
Standard Deviation 12
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD8+ TCM Cell Counts
Day 8 (N = 21)
|
0.010 100 cells/µL
Standard Deviation 0.013
|
—
|
—
|
|
CD8+ TCM Cell Counts
Day 15 (N = 16)
|
0.004 100 cells/µL
Standard Deviation 0.005
|
—
|
—
|
|
CD8+ TCM Cell Counts
Day 29 (N = 11)
|
0.007 100 cells/µL
Standard Deviation 0.007
|
—
|
—
|
|
CD8+ TCM Cell Counts
Day 43 (N = 8)
|
0.012 100 cells/µL
Standard Deviation 0.015
|
—
|
—
|
|
CD8+ TCM Cell Counts
End of Infusion (N = 9)
|
0.009 100 cells/µL
Standard Deviation 0.009
|
—
|
—
|
|
CD8+ TCM Cell Counts
End of Core Study (N = 6)
|
0.016 100 cells/µL
Standard Deviation 0.023
|
—
|
—
|
|
CD8+ TCM Cell Counts
3-Month Follow-up (N = 5)
|
0.008 100 cells/µL
Standard Deviation 0.003
|
—
|
—
|
|
CD8+ TCM Cell Counts
6-Month Follow-up (N = 6)
|
0.016 100 cells/µL
Standard Deviation 0.014
|
—
|
—
|
|
CD8+ TCM Cell Counts
9-Month Follow-up (N = 4)
|
0.006 100 cells/µL
Standard Deviation 0.004
|
—
|
—
|
|
CD8+ TCM Cell Counts
12-Month Follow-up (N = 4)
|
0.010 100 cells/µL
Standard Deviation 0.010
|
—
|
—
|
|
CD8+ TCM Cell Counts
15-Month Follow-up (N = 3)
|
0.004 100 cells/µL
Standard Deviation 0.002
|
—
|
—
|
|
CD8+ TCM Cell Counts
Screening (N = 25)
|
0.020 100 cells/µL
Standard Deviation 0.027
|
—
|
—
|
|
CD8+ TCM Cell Counts
Day 1 Prior (N = 24)
|
0.014 100 cells/µL
Standard Deviation 0.021
|
—
|
—
|
|
CD8+ TCM Cell Counts
18-Month Follow-up (N = 3)
|
0.002 100 cells/µL
Standard Deviation 0.001
|
—
|
—
|
|
CD8+ TCM Cell Counts
21-Month Follow-up (N = 21)
|
0.002 100 cells/µL
Standard Deviation 0.001
|
—
|
—
|
|
CD8+ TCM Cell Counts
24-Month Follow-up (N = 3)
|
0.006 100 cells/µL
Standard Deviation 0.004
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
Day 1 Prior (N = 24)
|
8 percentage of CD8+ T-cells
Standard Deviation 11
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
Day 8 (N = 21)
|
10 percentage of CD8+ T-cells
Standard Deviation 13
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
Day 15 (N = 16)
|
4 percentage of CD8+ T-cells
Standard Deviation 5
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
Day 29 (N = 11)
|
7 percentage of CD8+ T-cells
Standard Deviation 10
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
Day 43 (N = 8)
|
9 percentage of CD8+ T-cells
Standard Deviation 18
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
End of Infusion (N = 9)
|
5 percentage of CD8+ T-cells
Standard Deviation 6
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
End of Core Study (N = 6)
|
5 percentage of CD8+ T-cells
Standard Deviation 8
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
3-Month Follow-up (N = 5)
|
3 percentage of CD8+ T-cells
Standard Deviation 2
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
6-Month Follow-up (N = 6)
|
4 percentage of CD8+ T-cells
Standard Deviation 3
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
9-Month Follow-up (N = 4)
|
3 percentage of CD8+ T-cells
Standard Deviation 2
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
12-Month Follow-up (N = 4)
|
3 percentage of CD8+ T-cells
Standard Deviation 3
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
15-Month Follow-up (N = 3)
|
2 percentage of CD8+ T-cells
Standard Deviation 1
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
18-Month Follow-up (N = 3)
|
2 percentage of CD8+ T-cells
Standard Deviation 1
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
21-Month Follow-up (N = 21)
|
1 percentage of CD8+ T-cells
Standard Deviation 0
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
24-Month Follow-up (N = 3)
|
6 percentage of CD8+ T-cells
Standard Deviation 8
|
—
|
—
|
|
CD8+ TCM Cells as a Percentage of All CD8+ T-Cells
Screening (N = 25)
|
7 percentage of CD8+ T-cells
Standard Deviation 7
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD8+ Effector Memory T-Cell (TEM) Count
Screening (N = 25)
|
0.127 1000 cells/µL
Standard Deviation 0.162
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
Day 1 Prior (N = 24)
|
0.075 1000 cells/µL
Standard Deviation 0.066
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
Day 8 (N = 21)
|
0.065 1000 cells/µL
Standard Deviation 0.058
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
Day 15 (N = 16)
|
0.045 1000 cells/µL
Standard Deviation 0.053
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
Day 29 (N = 11)
|
0.067 1000 cells/µL
Standard Deviation 0.039
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
Day 43 (N = 8)
|
0.135 1000 cells/µL
Standard Deviation 0.108
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
End of Infusion (N = 9)
|
0.128 1000 cells/µL
Standard Deviation 0.077
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
End of Core Study (N = 6)
|
0.180 1000 cells/µL
Standard Deviation 0.089
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
3-Month Follow-up (N = 5)
|
0.146 1000 cells/µL
Standard Deviation 0.071
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
6-Month Follow-up (N = 6)
|
0.179 1000 cells/µL
Standard Deviation 0.158
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
9-Month Follow-up (N = 4)
|
0.116 1000 cells/µL
Standard Deviation 0.061
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
12-Month Follow-up (N = 4)
|
0.174 1000 cells/µL
Standard Deviation 0.162
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
15-Month Follow-up (N = 3)
|
0.095 1000 cells/µL
Standard Deviation 0.025
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
21-Month Follow-up (N = 21)
|
0.085 1000 cells/µL
Standard Deviation 0.013
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
24-Month Follow-up (N = 3)
|
0.054 1000 cells/µL
Standard Deviation 0.027
|
—
|
—
|
|
CD8+ Effector Memory T-Cell (TEM) Count
18-Month Follow-up (N = 3)
|
0.049 1000 cells/µL
Standard Deviation 0.027
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
Screening (N = 25)
|
42 percentage of CD8+ T-cells
Standard Deviation 19
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
Day 1 Prior (N = 24)
|
42 percentage of CD8+ T-cells
Standard Deviation 17
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
Day 8 (N = 21)
|
46 percentage of CD8+ T-cells
Standard Deviation 18
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
Day 15 (N = 16)
|
43 percentage of CD8+ T-cells
Standard Deviation 13
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
Day 29 (N = 11)
|
51 percentage of CD8+ T-cells
Standard Deviation 19
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
Day 43 (N = 8)
|
46 percentage of CD8+ T-cells
Standard Deviation 23
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
End of Infusion (N = 9)
|
51 percentage of CD8+ T-cells
Standard Deviation 21
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
End of Core Study (N = 6)
|
49 percentage of CD8+ T-cells
Standard Deviation 22
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
3-Month Follow-up (N = 5)
|
47 percentage of CD8+ T-cells
Standard Deviation 23
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
6-Month Follow-up (N = 6)
|
50 percentage of CD8+ T-cells
Standard Deviation 24
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
9-Month Follow-up (N = 4)
|
50 percentage of CD8+ T-cells
Standard Deviation 21
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
12-Month Follow-up (N = 4)
|
51 percentage of CD8+ T-cells
Standard Deviation 13
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
15-Month Follow-up (N = 3)
|
46 percentage of CD8+ T-cells
Standard Deviation 15
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
18-Month Follow-up (N = 3)
|
46 percentage of CD8+ T-cells
Standard Deviation 7
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
21-Month Follow-up (N = 21)
|
46 percentage of CD8+ T-cells
Standard Deviation 1
|
—
|
—
|
|
CD8+ TEM Cells as a Percentage of All CD8+ T-Cells
24-Month Follow-up (N = 3)
|
33 percentage of CD8+ T-cells
Standard Deviation 9
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
Screening (N = 25)
|
0.123 1000 cells/µL
Standard Deviation 0.099
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
Day 1 Prior (N = 24)
|
0.072 1000 cells/µL
Standard Deviation 0.069
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
Day 8 (N = 21)
|
0.051 1000 cells/µL
Standard Deviation 0.042
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
Day 15 (N = 16)
|
0.047 1000 cells/µL
Standard Deviation 0.048
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
Day 29 (N = 11)
|
0.058 1000 cells/µL
Standard Deviation 0.050
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
Day 43 (N = 8)
|
0.132 1000 cells/µL
Standard Deviation 0.126
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
End of Infusion (N = 9)
|
0.135 1000 cells/µL
Standard Deviation 0.131
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
End of Core Study (N = 6)
|
0.226 1000 cells/µL
Standard Deviation 0.249
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
3-Month Follow-up (N = 5)
|
0.214 1000 cells/µL
Standard Deviation 0.220
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
6-Month Follow-up (N = 6)
|
0.187 1000 cells/µL
Standard Deviation 0.182
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
9-Month Follow-up (N = 4)
|
0.094 1000 cells/µL
Standard Deviation 0.046
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
12-Month Follow-up (N = 4)
|
0.117 1000 cells/µL
Standard Deviation 0.065
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
15-Month Follow-up (N = 3)
|
0.099 1000 cells/µL
Standard Deviation 0.041
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
18-Month Follow-up (N = 3)
|
0.047 1000 cells/µL
Standard Deviation 0.035
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
21-Month Follow-up (N = 21)
|
0.086 1000 cells/µL
Standard Deviation 0.016
|
—
|
—
|
|
CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count
24-Month Follow-up (N = 3)
|
0.100 1000 cells/µL
Standard Deviation 0.084
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessmentPopulation: Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).
Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.
Outcome measures
| Measure |
Cohort 1: Blinatumomab 9/28/112 μg/d
n=25 Participants
Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 μg/d
Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 μg/d
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
|---|---|---|---|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
Screening (N = 25)
|
41 percentage of CD8+ T-cells
Standard Deviation 19
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
Day 1 Prior (N = 24)
|
39 percentage of CD8+ T-cells
Standard Deviation 19
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
Day 8 (N = 21)
|
36 percentage of CD8+ T-cells
Standard Deviation 19
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
Day 15 (N = 16)
|
46 percentage of CD8+ T-cells
Standard Deviation 17
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
Day 29 (N = 11)
|
34 percentage of CD8+ T-cells
Standard Deviation 20
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
Day 43 (N = 8)
|
39 percentage of CD8+ T-cells
Standard Deviation 26
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
End of Infusion (N = 9)
|
41 percentage of CD8+ T-cells
Standard Deviation 24
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
End of Core Study (N = 6)
|
41 percentage of CD8+ T-cells
Standard Deviation 24
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
3-Month Follow-up (N = 5)
|
46 percentage of CD8+ T-cells
Standard Deviation 26
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
6-Month Follow-up (N = 6)
|
41 percentage of CD8+ T-cells
Standard Deviation 21
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
9-Month Follow-up (N = 4)
|
42 percentage of CD8+ T-cells
Standard Deviation 18
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
12-Month Follow-up (N = 4)
|
40 percentage of CD8+ T-cells
Standard Deviation 15
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
15-Month Follow-up (N = 3)
|
46 percentage of CD8+ T-cells
Standard Deviation 17
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
18-Month Follow-up (N = 3)
|
43 percentage of CD8+ T-cells
Standard Deviation 12
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
21-Month Follow-up (N = 21)
|
45 percentage of CD8+ T-cells
Standard Deviation 3
|
—
|
—
|
|
CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells
24-Month Follow-up (N = 3)
|
51 percentage of CD8+ T-cells
Standard Deviation 22
|
—
|
—
|
Adverse Events
Cohort 1: Blinatumomab 9/28/112 µg/d
Cohort 2: Blinatumomab 112 µg/d
Cohort 3: Blinatumomab 9/28/112 µg/d
Cohort 1+3: Blinatumomab 9/28/112µg/d
Blinatumomab Overall
Serious adverse events
| Measure |
Cohort 1: Blinatumomab 9/28/112 µg/d
n=9 participants at risk
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 µg/d
n=2 participants at risk
Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 µg/d
n=14 participants at risk
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 1+3: Blinatumomab 9/28/112µg/d
n=23 participants at risk
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Blinatumomab Overall
n=25 participants at risk
All participants who received blinatumomab by continuous intravenous infusion during the core study.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Bone marrow toxicity
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Supraventricular tachycardia
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Adrenal insufficiency
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Disease progression
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pain
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.3%
2/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.0%
3/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.0%
4/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Device related infection
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
35.7%
5/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
21.7%
5/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
5/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Herpes virus infection
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lobar pneumonia
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lung infection
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
33.3%
3/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.3%
2/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
21.7%
5/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
24.0%
6/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral infection
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Aphasia
|
22.2%
2/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Encephalopathy
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neurological symptom
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Speech disorder
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
22.2%
2/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Cohort 1: Blinatumomab 9/28/112 µg/d
n=9 participants at risk
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 2: Blinatumomab 112 µg/d
n=2 participants at risk
Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 3: Blinatumomab 9/28/112 µg/d
n=14 participants at risk
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Cohort 1+3: Blinatumomab 9/28/112µg/d
n=23 participants at risk
Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
|
Blinatumomab Overall
n=25 participants at risk
All participants who received blinatumomab by continuous intravenous infusion during the core study.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
21.4%
3/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
17.4%
4/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.0%
4/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
28.6%
4/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
21.7%
5/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
5/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Tachycardia
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Deafness
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo
|
22.2%
2/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Keratitis
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
44.4%
4/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
21.7%
5/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
24.0%
6/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.3%
2/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Odynophagia
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Catheter site erythema
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Catheter site rash
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chills
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.3%
2/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.0%
3/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.0%
3/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Disease progression
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
21.4%
3/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.0%
3/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.0%
3/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Facial pain
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
33.3%
3/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
21.4%
3/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
26.1%
6/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
28.0%
7/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
General physical health deterioration
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Mucosal inflammation
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
35.7%
5/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
26.1%
6/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
24.0%
6/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema peripheral
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pain
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
44.4%
4/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
35.7%
5/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
39.1%
9/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.0%
10/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Ulcer
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Drug hypersensitivity
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Candida infection
|
22.2%
2/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Candiduria
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diverticulitis
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Fungal infection
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Herpes simplex
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infection
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
21.4%
3/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.0%
3/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.0%
3/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Otitis media
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Respiratory tract infection
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Rhinitis
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Antithrombin III decreased
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood glucose increased
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
28.6%
4/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
17.4%
4/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.0%
4/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood immunoglobulin G decreased
|
22.2%
2/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood magnesium decreased
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood sodium decreased
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
C-reactive protein increased
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
21.4%
3/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
17.4%
4/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.0%
4/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Corneal reflex decreased
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Fibrin D dimer increased
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Fibrinolysis increased
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
PO2 decreased
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Weight increased
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
21.4%
3/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.0%
3/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.0%
3/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
22.2%
2/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.3%
2/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
17.4%
4/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
5/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
21.4%
3/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
17.4%
4/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.0%
4/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Vitamin K deficiency
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.3%
2/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.0%
3/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.0%
3/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
22.2%
2/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.0%
3/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ataxia
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dyscalculia
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Epilepsy
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Memory impairment
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Somnolence
|
22.2%
2/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Speech disorder
|
33.3%
3/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.0%
3/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.0%
4/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Tremor
|
66.7%
6/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
100.0%
2/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
28.6%
4/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
43.5%
10/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
48.0%
12/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Vocal cord paralysis
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Confusional state
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Disorientation
|
22.2%
2/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.0%
3/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Encopresis
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Fear
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.3%
2/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.3%
2/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Enuresis
|
22.2%
2/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Haematuria
|
22.2%
2/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
2/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
3/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
17.4%
4/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
5/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
1/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.3%
2/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.0%
3/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.0%
3/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.3%
2/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.0%
3/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.0%
3/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Embolism
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Haematoma
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/9 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/2 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
1/14 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
1/23 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From the first dose of blinatumomab until up to 30 days after the last dose, until the data cut-off date of 10 July 2014; the overall median duration of treatment exposure was 46.8 days.
Adverse Events were not pre-specified to be monitored/assessed after 10 July 2014. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen, Inc.
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