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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

During the first 8 weeks

Results posted on

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

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

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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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

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

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

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

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

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

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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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

Serious events: 9 serious events
Other events: 9 other events
Deaths: 0 deaths

Cohort 2: Blinatumomab 112 µg/d

Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths

Cohort 3: Blinatumomab 9/28/112 µg/d

Serious events: 12 serious events
Other events: 14 other events
Deaths: 0 deaths

Cohort 1+3: Blinatumomab 9/28/112µg/d

Serious events: 21 serious events
Other events: 23 other events
Deaths: 0 deaths

Blinatumomab Overall

Serious events: 23 serious events
Other events: 25 other events
Deaths: 0 deaths

Serious adverse events

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

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.

Phone: 866-572-6436

Results disclosure agreements

  • Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
  • Publication restrictions are in place

Restriction type: OTHER