Trial Outcomes & Findings for A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (NCT NCT02961881)

NCT ID: NCT02961881

Last Updated: 2024-02-02

Results Overview

The occurrence of any of the following toxicities during the DLT evaluation period was considered a DLT, if judged by the investigator to be related to the administration of blinatumomab: * Death * Any toxicity, regardless of grade, that lead to a participant's removal from the study by the investigator and/or sponsor * Persistent Common Terminology Criteria for Adverse Events (CTCAE) grade \>/= 2 non-hematologic adverse events (AEs) that were deemed intolerable by the participant or the treating physician and that did not respond to appropriate medical management within 5 days and lead to treatment discontinuation * Recurrent grade 2 seizures * All grade 3 and 4 AEs and laboratory abnormalities, which occurred during the SC administration portion of the treatment period with exceptions noted in protocol section 6.2.1.2.3.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

35 participants

Primary outcome timeframe

Day 1 to Day 7 of Week 4

Results posted on

2024-02-02

Participant Flow

Of the 39 participants screened, 35 participants were enrolled at 10 centers in the United States, Europe and Australia between 18 September 2017 and 02 September 2021.

The participants underwent an initial continuous intravenous (cIV) blinatumomab run-in period (Weeks 1 to 3). The participants received subcutaneous (SC) administration at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, participants received cIV treatment to complete 6 weeks of therapy (Weeks 5 to 6).

Participant milestones

Participant milestones
Measure
Blinatumomab Cohort 1
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 112 μq SC administrations every 12 hours (q12h) for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab Cohort 2
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab Cohort 3
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 450 μq SC administrations every 24 hours (q24h) for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab Cohort 4
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab Cohort 5
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 675 μq SC administrations every 48 hours (q48h) for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Overall Study
STARTED
7
8
8
6
6
Overall Study
Started Week 4 SC Dosing
6
7
7
6
5
Overall Study
Started Week 5-6 cIV Dosing
6
5
6
6
5
Overall Study
COMPLETED
5
4
5
6
5
Overall Study
NOT COMPLETED
2
4
3
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Blinatumomab Cohort 1
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 112 μq SC administrations every 12 hours (q12h) for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab Cohort 2
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab Cohort 3
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 450 μq SC administrations every 24 hours (q24h) for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab Cohort 4
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab Cohort 5
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 675 μq SC administrations every 48 hours (q48h) for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Overall Study
Adverse Event
1
2
2
0
1
Overall Study
Participant request
0
2
0
0
0
Overall Study
Disease progression
1
0
1
0
0

Baseline Characteristics

A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Blinatumomab Cohort 5
n=6 Participants
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Total
n=35 Participants
Total of all reporting groups
Blinatumomab Cohort 1
n=7 Participants
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab Cohort 2
n=8 Participants
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab Cohort 3
n=8 Participants
Blinatumomab Cohort 3 The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab Cohort 4
n=6 Participants
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Age, Customized
18 - 64 years
5 Participants
n=21 Participants
21 Participants
n=8 Participants
5 Participants
n=5 Participants
5 Participants
n=7 Participants
3 Participants
n=5 Participants
3 Participants
n=4 Participants
Age, Customized
65 - 74 years
1 Participants
n=21 Participants
13 Participants
n=8 Participants
2 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
3 Participants
n=4 Participants
Age, Customized
75 - 84 years
0 Participants
n=21 Participants
1 Participants
n=8 Participants
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Customized
≥ 85 years
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Sex: Female, Male
Female
1 Participants
n=21 Participants
16 Participants
n=8 Participants
3 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
3 Participants
n=4 Participants
Sex: Female, Male
Male
5 Participants
n=21 Participants
19 Participants
n=8 Participants
4 Participants
n=5 Participants
4 Participants
n=7 Participants
3 Participants
n=5 Participants
3 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=21 Participants
2 Participants
n=8 Participants
1 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
n=21 Participants
33 Participants
n=8 Participants
6 Participants
n=5 Participants
7 Participants
n=7 Participants
8 Participants
n=5 Participants
6 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race/Ethnicity, Customized
Asian
0 Participants
n=21 Participants
1 Participants
n=8 Participants
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race/Ethnicity, Customized
Black (or African American)
0 Participants
n=21 Participants
1 Participants
n=8 Participants
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race/Ethnicity, Customized
Multiple
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race/Ethnicity, Customized
White
6 Participants
n=21 Participants
31 Participants
n=8 Participants
4 Participants
n=5 Participants
7 Participants
n=7 Participants
8 Participants
n=5 Participants
6 Participants
n=4 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=21 Participants
2 Participants
n=8 Participants
2 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 7 of Week 4

Population: DLT analysis set included DLT-evaluable participants who received all (q48h dosing), \>/= 4/5 (q24h dosing) or \>/= 8/9 (q12h dosing) doses of SC blinatumomab or experienced a DLT during the DLT evaluable period.

The occurrence of any of the following toxicities during the DLT evaluation period was considered a DLT, if judged by the investigator to be related to the administration of blinatumomab: * Death * Any toxicity, regardless of grade, that lead to a participant's removal from the study by the investigator and/or sponsor * Persistent Common Terminology Criteria for Adverse Events (CTCAE) grade \>/= 2 non-hematologic adverse events (AEs) that were deemed intolerable by the participant or the treating physician and that did not respond to appropriate medical management within 5 days and lead to treatment discontinuation * Recurrent grade 2 seizures * All grade 3 and 4 AEs and laboratory abnormalities, which occurred during the SC administration portion of the treatment period with exceptions noted in protocol section 6.2.1.2.3.

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=6 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=6 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=7 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=6 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=5 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Number of Participants With Dose Limiting-Toxicities (DLTs) After SC Administration
0 Participants
1 Participants
1 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 7 of Week 4

Population: DLT analysis set included DLT-evaluable participants who received all (q48h dosing), \>/= 4/5 (q24h dosing) or \>/= 8/9 (q12h dosing) doses of SC blinatumomab or experienced a DLT during the DLT evaluable period.

All toxicities were graded using the CTCAE version 4.0: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = fatal.

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=6 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=6 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=7 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=6 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=5 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Number of Participants With DLTs CTCAE Grade ≥ 3 After SC Administration
0 Participants
1 Participants
1 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Day 1 to end of study (approximately 17 weeks)

Population: Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.

An AE was defined as any untoward medical occurrence in a clinical study participant. The AE did not necessarily have a causal relationship with study treatment. The definition of AEs included worsening of a pre-existing medical condition. TEAEs included AEs starting on or after first dose of investigational product and up to the end of study date. All AEs were graded using the CTCAE version 4.0: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = fatal.

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=6 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=7 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=7 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=6 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=5 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) After SC Administration
Any TEAEs
2 Participants
6 Participants
6 Participants
6 Participants
4 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) After SC Administration
Any TEAEs CTCAE Grade ≥ 3
1 Participants
1 Participants
2 Participants
1 Participants
0 Participants

SECONDARY outcome

Timeframe: Once at any timepoint during Day 2 of Weeks 1, 2, 3, 5 and 6

Population: Pharmacokinetic (PK) analyses set included all participants who received any cIV blinatumomab and had at least one PK sample. These participants were evaluated for PK unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption, or sampling information was missing. Css data during cIV dosing was reported per dose level as pre-specified in statistical analysis plan (SAP) section 10.7.

Summarized as the observed concentrations collected after 5 half-lives after the start of the IV infusion of each dose (i.e., 9, 28 and 112 μg/day).

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=29 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=31 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=29 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=26 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Steady State Serum Concentration (Css) of Blinatumomab After cIV Administration
238 pg/mL
Geometric Coefficient of Variation 137
672 pg/mL
Geometric Coefficient of Variation 94
2780 pg/mL
Geometric Coefficient of Variation 87
2700 pg/mL
Geometric Coefficient of Variation 85

SECONDARY outcome

Timeframe: Once at any timepoint during Day 2 of Weeks 1, 2, 3, 5 and 6

Population: PK analyses set included all participants who received any cIV blinatumomab and had at least one PK sample. These participants were evaluated for PK unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption, or sampling information was missing. CL data prior to SC dosing was dose-normalized and reported together as pre-specified in SAP section 10.7.

Calculated as CL=R0/Css; where R0 is the infusion rate (μg/hr) and Css is the average Css. Both R0 and Css were dose-normalized to 112 μg/day for this calculation.

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=33 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=26 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Systemic Clearance (CL) of Blinatumomab After cIV Administration
1.67 L/hr
Geometric Coefficient of Variation 111
1.73 L/hr
Geometric Coefficient of Variation 85

SECONDARY outcome

Timeframe: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)

Population: PK analyses set included all participants who received any SC blinatumomab and had at least one PK sample. These participants were evaluated for PK unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption, or sampling information was missing. Descriptive statistics for first SC dose of 675 μg on Week 4 Day 1 were determined using parameter estimates from participants in Cohorts 4 and 5 as pre-specified in SAP section 10.7.

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=6 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=7 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=7 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=10 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=6 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=4 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Maximum Observed Concentration (Cmax) of Blinatumomab After SC Administration
Week 4 Day 1
877 pg/mL
Geometric Coefficient of Variation 88
1810 pg/mL
Geometric Coefficient of Variation 93
2650 pg/mL
Geometric Coefficient of Variation 98
4260 pg/mL
Geometric Coefficient of Variation 103
Maximum Observed Concentration (Cmax) of Blinatumomab After SC Administration
Week 4 Day 5
2070 pg/mL
Geometric Coefficient of Variation 15
4340 pg/mL
Geometric Coefficient of Variation 36
4290 pg/mL
Geometric Coefficient of Variation 98
5690 pg/mL
Geometric Coefficient of Variation 71
4340 pg/mL
Geometric Coefficient of Variation 304

SECONDARY outcome

Timeframe: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)

Population: PK analyses set included all participants who received any SC blinatumomab and had at least one PK sample. These participants were evaluated for PK unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption, or sampling information was missing. Descriptive statistics for first SC dose of 675 μg on Week 4 Day 1 were determined using parameter estimates from participants in Cohorts 4 and 5 as pre-specified in SAP section 10.7.

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=6 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=7 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=7 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=10 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=6 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=4 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Time at Which Cmax (Tmax) Occurred of Blinatumomab After SC Administration
Week 4 Day 5
2.8 hours
Interval 0.0 to 8.0
4.0 hours
Interval 0.0 to 6.1
7.6 hours
Interval 6.0 to 12.0
8.0 hours
Interval 4.0 to 12.0
9.5 hours
Interval 2.2 to 12.0
Time at Which Cmax (Tmax) Occurred of Blinatumomab After SC Administration
Week 4 Day 1
5.0 hours
Interval 0.0 to 8.1
7.9 hours
Interval 1.0 to 8.1
12 hours
Interval 7.2 to 12.0
12 hours
Interval 1.9 to 12.0

SECONDARY outcome

Timeframe: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)

Population: PK analyses set included all participants who received any SC blinatumomab and had at least one PK sample. These participants were evaluated for PK unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption, or sampling information was missing. At Week 4 Day 1, AUCt was only reported for SC dosing regimens in Cohorts 1 and 2 as PK sampling was taken only over the 12-hour period following dosing as pre-specified in protocol section 7.1.

Estimated using the linear trapezoidal method; where t is a dosing interval. AUC over the dosing interval, t where t is 12 hours for Cohorts 1 and 2, 24 hours for Cohorts 3 and 4, and 48 hours for Cohort 5.

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=6 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=5 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=6 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=6 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=4 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Area Under the Concentration-time Curve (AUC) of Blinatumomab After SC Administration for a Dosing Interval t (AUCt)
Week 4 Day 1
6080 hr•pg/mL
Geometric Coefficient of Variation 80
9430 hr•pg/mL
Geometric Coefficient of Variation 40
Area Under the Concentration-time Curve (AUC) of Blinatumomab After SC Administration for a Dosing Interval t (AUCt)
Week 4 Day 5
19100 hr•pg/mL
Geometric Coefficient of Variation 21
40500 hr•pg/mL
Geometric Coefficient of Variation 41
72000 hr•pg/mL
Geometric Coefficient of Variation 92
90900 hr•pg/mL
Geometric Coefficient of Variation 77
90800 hr•pg/mL
Geometric Coefficient of Variation 236

SECONDARY outcome

Timeframe: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)

Population: PK analyses set included all participants who received any SC blinatumomab and had at least one PK sample. These participants were evaluated for PK unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption, or sampling information was missing. At Week 4 Day 1, Cmin was only reported for SC dosing regimens in Cohorts 1 and 2 as PK sampling was taken only over the 12-hour period following dosing as pre-specified in protocol section 7.1.

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=6 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=6 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=6 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=6 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=4 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Minimum Observed Concentration (Cmin) of Blinatumomab After SC Administration
Week 4 Day 1
651 pg/mL
Geometric Coefficient of Variation 93
1470 pg/mL
Geometric Coefficient of Variation 101
Minimum Observed Concentration (Cmin) of Blinatumomab After SC Administration
Week 4 Day 5
1290 pg/mL
Geometric Coefficient of Variation 30
2550 pg/mL
Geometric Coefficient of Variation 41
1950 pg/mL
Geometric Coefficient of Variation 94
2130 pg/mL
Geometric Coefficient of Variation 104
147 pg/mL
Geometric Coefficient of Variation 66

SECONDARY outcome

Timeframe: Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)

Population: PK analyses set included all participants who received any SC blinatumomab and had at least one PK sample. These participants were evaluated for PK unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption, or sampling information was missing.

Calculated as CL/F = Dose sc / AUCt-ss (at steady state).

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=6 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=5 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=6 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=6 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=4 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Apparent Clearance (CL/F) of Blinatumomab After SC Administration
5.85 L/hr
Geometric Coefficient of Variation 21
5.55 L/hr
Geometric Coefficient of Variation 41
6.25 L/hr
Geometric Coefficient of Variation 92
7.43 L/hr
Geometric Coefficient of Variation 77
7.43 L/hr
Geometric Coefficient of Variation 236

SECONDARY outcome

Timeframe: Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)

Population: PK analyses set included all participants who received any SC blinatumomab and had at least one PK sample. These participants were evaluated for PK unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption, or sampling information was missing.

Calculated as Vz/F=CL/F / λz, where λz was the first-order rate constant estimated via linear regression of the terminal log-linear decay phase as determined from the noncompartmental analysis.

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=6 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=5 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=3 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=4 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=2 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Volume of Distribution Based on Terminal Phase (Vz/F) of Blinatumomab After SC Administration
83.4 liters
Geometric Coefficient of Variation 19
100 liters
Geometric Coefficient of Variation 93
58.6 liters
Geometric Coefficient of Variation 115
120 liters
Geometric Coefficient of Variation 97
133 liters
Geometric Coefficient of Variation 9623

SECONDARY outcome

Timeframe: Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)

Population: PK analyses set included all participants who received any SC blinatumomab and had at least one PK sample. These participants were evaluated for PK unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption, or sampling information was missing.

Calculated as t1/2,z = ln(2) / λz.

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=6 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=4 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=3 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=4 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=2 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Terminal Half-life (t1/2,z) of Blinatumomab After SC Administration
9.87 hours
Geometric Coefficient of Variation 12
10.7 hours
Geometric Coefficient of Variation 22
7.30 hours
Geometric Coefficient of Variation 21
11.7 hours
Geometric Coefficient of Variation 30
9.20 hours
Geometric Coefficient of Variation 83

SECONDARY outcome

Timeframe: Week 4 Day 1 (pre-dose and 1, 2, 4, 6, 8 and 12 hours post-dose) and Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)

Population: PK analyses set included all participants who received any SC blinatumomab and had at least one PK sample. These participants were evaluated for PK unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption, or sampling information was missing.

Calculated as the ratio of AUCt (last SC dose; Week 4 Day 5) / AUC (first SC dose; Week 4 Day 1).

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=5 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=2 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=2 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=5 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=3 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Accumulation Ratio of Blinatumomab After SC Administration
3.25 ratio
Geometric Coefficient of Variation 61
4.14 ratio
Geometric Coefficient of Variation 35
2.31 ratio
Geometric Coefficient of Variation 63
1.71 ratio
Geometric Coefficient of Variation 109
1.01 ratio
Geometric Coefficient of Variation 107

SECONDARY outcome

Timeframe: Week 4 Day 5 (pre-dose and 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose)

Population: PK analyses set included all participants who received any SC blinatumomab and had at least one PK sample. These participants were evaluated for PK unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption, or sampling information was missing.

Calculated as F = (CL \* AUCt-ss) / Dose sc.

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=6 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=5 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=5 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=6 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=4 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Bioavailability (F) of SC Blinatumomab
32.1 percent bioavailability
Geometric Coefficient of Variation 38
22.5 percent bioavailability
Geometric Coefficient of Variation 54
33.8 percent bioavailability
Geometric Coefficient of Variation 215
24.6 percent bioavailability
Geometric Coefficient of Variation 53
30.2 percent bioavailability
Geometric Coefficient of Variation 180

SECONDARY outcome

Timeframe: Day 1 to Day 7 of Week 4

Population: DLT analysis set included all DLT-evaluable participants who received all doses (q48h), at least 4/5 doses (q24h) or at least 8/9 doses (q12h) of SC blinatumomab.

The MTD was defined as the highest dose level at which \</= 1 of 6 participants experienced a DLT.

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=30 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Maximum Tolerated Dose (MTD) of SC Blinatumomab
NA μq
The MTD was not reached in this study.

SECONDARY outcome

Timeframe: Predose at the re-start of cIV infusion (Week 5 Day 1)

Population: Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=6 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=7 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=7 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=6 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=5 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Number of Participants With Anti-blinatumomab Antibody Formation After SC Administration
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Day 1 to end of study (approximately 17 weeks)

Population: Full analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.

Percentage of participants achieving ORR (complete response \[CR\] + partial response \[PR\]) was determined by best overall response using Cheson criteria: * CR: disappearance of all evidence of disease. * PR: regression of measurable disease and no new sites. The 95% confidence interval (CI) was calculated using Clopper-Pearson exact CI. Participants were considered as non-responders if there was no response assessment available.

Outcome measures

Outcome measures
Measure
Blinatumomab SC Cohort 1
n=6 Participants
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=7 Participants
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=7 Participants
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=6 Participants
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=5 Participants
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Overall Response Rate (ORR) After SC Administration
66.7 percentage of participants
Interval 22.3 to 95.7
71.4 percentage of participants
Interval 29.0 to 96.3
71.4 percentage of participants
Interval 29.0 to 96.3
83.3 percentage of participants
Interval 35.9 to 99.6
40.0 percentage of participants
Interval 5.3 to 85.3

Adverse Events

Blinatumomab cIV Before SC Week 1

Serious events: 5 serious events
Other events: 23 other events
Deaths: 1 deaths

Blinatumomab cIV Before SC Week 2

Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths

Blinatumomab cIV Before SC Week 3

Serious events: 8 serious events
Other events: 23 other events
Deaths: 0 deaths

Blinatumomab SC Cohort 1

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

Blinatumomab SC Cohort 2

Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths

Blinatumomab SC Cohort 3

Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths

Blinatumomab SC Cohort 4

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Blinatumomab SC Cohort 5

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Blinatumomab cIV After SC

Serious events: 10 serious events
Other events: 19 other events
Deaths: 1 deaths

Blinatumomab SC Total

Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths

Blinatumomab cIV Total

Serious events: 18 serious events
Other events: 34 other events
Deaths: 2 deaths

Blinatumomab SC + cIV Total

Serious events: 19 serious events
Other events: 35 other events
Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure
Blinatumomab cIV Before SC Week 1
n=35 participants at risk
The participants received 9 μq/day cIV administrations during Week 1.
Blinatumomab cIV Before SC Week 2
n=34 participants at risk
The participants received 28 μq/day cIV administrations during Week 2.
Blinatumomab cIV Before SC Week 3
n=33 participants at risk
The participants received 112 μq/day cIV administrations during Week 3.
Blinatumomab SC Cohort 1
n=6 participants at risk
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=7 participants at risk
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=7 participants at risk
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=6 participants at risk
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=5 participants at risk
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab cIV After SC
n=28 participants at risk
After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab SC Total
n=31 participants at risk
The participants received SC administrations for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab cIV Total
n=35 participants at risk
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab SC + cIV Total
n=35 participants at risk
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received SC administrations for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blood and lymphatic system disorders
Anaemia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Blood and lymphatic system disorders
Febrile neutropenia
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Gastrointestinal disorders
Erosive oesophagitis
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
General disorders
Pyrexia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Immune system disorders
Cytokine release syndrome
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.1%
2/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Infections and infestations
Dermo-hypodermitis
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Infections and infestations
Device related sepsis
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Infections and infestations
Pneumonia
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Infections and infestations
Sepsis
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Investigations
Platelet count decreased
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marginal zone lymphoma refractory
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Aphasia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Ataxia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Cognitive disorder
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Coordination abnormal
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Dysarthria
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Hemiparesis
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Motor dysfunction
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Nervous system disorder
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.1%
2/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Neurological symptom
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Neurotoxicity
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Seizure
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Psychiatric disorders
Confusional state
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Psychiatric disorders
Hallucination
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Vascular disorders
Hypotension
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.

Other adverse events

Other adverse events
Measure
Blinatumomab cIV Before SC Week 1
n=35 participants at risk
The participants received 9 μq/day cIV administrations during Week 1.
Blinatumomab cIV Before SC Week 2
n=34 participants at risk
The participants received 28 μq/day cIV administrations during Week 2.
Blinatumomab cIV Before SC Week 3
n=33 participants at risk
The participants received 112 μq/day cIV administrations during Week 3.
Blinatumomab SC Cohort 1
n=6 participants at risk
The participants received 112 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 2
n=7 participants at risk
The participants received 225 μq SC administrations q12h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 3
n=7 participants at risk
The participants received 450 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 4
n=6 participants at risk
The participants received 675 μq SC administrations q24h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab SC Cohort 5
n=5 participants at risk
The participants received 675 μq SC administrations q48h for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab cIV After SC
n=28 participants at risk
After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab SC Total
n=31 participants at risk
The participants received SC administrations for 5 days at Week 4 followed by a treatment free period of 2 to 3 days.
Blinatumomab cIV Total
n=35 participants at risk
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blinatumomab SC + cIV Total
n=35 participants at risk
The participants underwent an initial cIV blinatumomab run-in period (Weeks 1 to 3) in which doses increased each week as follows: Week 1: 9 μq/day; Week 2: 28 μq/day; and Week 3: 112 μq/day. The run-in period was followed by a 12-hour treatment free period. The participants then received SC administrations for 5 days at Week 4 followed by a treatment free period of 2 to 3 days. After the SC administration period, the participants received 112 μq/day cIV blinatumomab during Weeks 5 and 6.
Blood and lymphatic system disorders
Anaemia
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.9%
2/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
10.7%
3/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.5%
2/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
5/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
17.1%
6/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.1%
2/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
16.7%
1/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
21.4%
6/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
22.9%
8/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
22.9%
8/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Blood and lymphatic system disorders
Thrombocytopenia
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
5/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Cardiac disorders
Palpitations
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Ear and labyrinth disorders
Vertigo
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.1%
2/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
28.6%
2/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.5%
2/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Eye disorders
Vision blurred
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
16.7%
1/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Gastrointestinal disorders
Abdominal pain
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
20.0%
1/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Gastrointestinal disorders
Constipation
17.1%
6/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.8%
3/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
12.1%
4/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
10.7%
3/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
37.1%
13/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
40.0%
14/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Gastrointestinal disorders
Diarrhoea
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.9%
2/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.1%
2/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
17.9%
5/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
22.9%
8/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
22.9%
8/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Gastrointestinal disorders
Dyspepsia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.1%
2/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Gastrointestinal disorders
Nausea
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.8%
3/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.1%
2/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
5/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
17.1%
6/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Gastrointestinal disorders
Oesophagitis
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Gastrointestinal disorders
Paraesthesia oral
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Gastrointestinal disorders
Vomiting
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.9%
2/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
General disorders
Administration site erythema
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
General disorders
Asthenia
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.8%
4/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.1%
2/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
16.7%
1/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
17.9%
5/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.5%
2/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
20.0%
7/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
20.0%
7/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
General disorders
Fatigue
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.9%
2/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
5/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
5/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
General disorders
Mucosal inflammation
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Injury, poisoning and procedural complications
Fall
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
20.0%
1/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
General disorders
Oedema
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
General disorders
Oedema peripheral
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
10.7%
3/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
General disorders
Pyrexia
20.0%
7/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.8%
3/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
33.3%
11/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
16.7%
1/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
4/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.5%
2/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
48.6%
17/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
51.4%
18/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Immune system disorders
Cytokine release syndrome
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
16.7%
1/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
40.0%
2/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
12.9%
4/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
17.1%
6/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Infections and infestations
Cytomegalovirus infection
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Infections and infestations
Device related infection
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Infections and infestations
Escherichia infection
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
20.0%
1/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Infections and infestations
Mucosal infection
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
20.0%
1/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Infections and infestations
Nasopharyngitis
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Infections and infestations
Oral herpes
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Infections and infestations
Respiratory tract infection
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.9%
2/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Investigations
Platelet count decreased
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.1%
2/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Injury, poisoning and procedural complications
Skin laceration
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
20.0%
1/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Investigations
Alanine aminotransferase increased
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Investigations
Aspartate aminotransferase increased
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.1%
2/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Investigations
Blood alkaline phosphatase increased
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Investigations
Body temperature increased
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
20.0%
1/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Investigations
Weight decreased
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Metabolism and nutrition disorders
Folate deficiency
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
16.7%
1/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Metabolism and nutrition disorders
Hyperglycaemia
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
16.7%
1/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Metabolism and nutrition disorders
Hyperkalaemia
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
28.6%
2/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.5%
2/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
9.1%
3/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Metabolism and nutrition disorders
Steroid diabetes
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Musculoskeletal and connective tissue disorders
Arthralgia
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
16.7%
1/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
5/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Musculoskeletal and connective tissue disorders
Back pain
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
5/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Musculoskeletal and connective tissue disorders
Bone pain
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.9%
2/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
5/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
5/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
20.0%
1/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
10.7%
3/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
5/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Musculoskeletal and connective tissue disorders
Myalgia
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Musculoskeletal and connective tissue disorders
Pain in extremity
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.1%
2/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
5/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
5/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Aphasia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
28.6%
2/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.5%
2/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Cognitive disorder
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.1%
2/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
16.7%
1/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.5%
2/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Disturbance in attention
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
16.7%
1/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Dizziness
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.9%
2/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
9.1%
3/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Dysarthria
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Dysgraphia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Encephalopathy
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Headache
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.8%
3/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
18.2%
6/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
28.6%
2/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
25.0%
7/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
9.7%
3/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
42.9%
15/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
45.7%
16/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Nervous system disorder
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
9.1%
3/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
20.0%
1/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Neurotoxicity
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
9.1%
3/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
16.7%
1/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
33.3%
2/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
12.9%
4/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
5/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
20.0%
7/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Paraesthesia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.1%
2/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Subdural hygroma
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Nervous system disorders
Tremor
11.4%
4/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
27.3%
9/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
33.3%
2/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
4/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.5%
2/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
34.3%
12/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
34.3%
12/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Psychiatric disorders
Agitation
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Psychiatric disorders
Anxiety
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Psychiatric disorders
Confusional state
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
6.1%
2/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Psychiatric disorders
Insomnia
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.9%
2/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
16.7%
1/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
9.7%
3/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
20.0%
7/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
25.7%
9/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Psychiatric disorders
Irritability
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
20.0%
1/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Skin and subcutaneous tissue disorders
Erythema
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.0%
1/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
16.7%
1/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
8.6%
3/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
7.1%
2/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Skin and subcutaneous tissue disorders
Skin reaction
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
14.3%
1/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Surgical and medical procedures
Astringent therapy
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.6%
1/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
5.7%
2/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
Vascular disorders
Hypertension
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/34 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/33 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/7 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/6 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
20.0%
1/5 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/28 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
3.2%
1/31 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
0.00%
0/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.
2.9%
1/35 • Day 1 to end of study (approximately 17 weeks)
Safety analysis set included participants that were enrolled and received at least 1 dose of blinatumomab.

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