Trial Outcomes & Findings for Safety and Efficacy of Blinatumomab in Adults With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma (NCT NCT03023878)

Last Updated: 2020-09-14

Results Overview

Overall incidence and severity of treatment-emergent adverse events occurring during the blinatumomab investigative product (IP) treatment period graded by investigators according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and based on the scale: Grade 1 = Mild - transient or mild discomfort; Grade 2 = Moderate - mild to moderate limitation in activity, assistance may be needed; minimal medical intervention required; Grade 3 = Severe - marked limitation in activity, assistance usually required; medical intervention required, hospitalization is possible; Grade 4 = Life threatening - extreme limitation in activity, assistance required; medical intervention, hospitalization or hospice care probable; Grade 5 = death.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

From the start of first infusion of IP to 30 days after the end of last infusion of IP; median (min, max) treatment duration was 56 (16, 84) days

Results posted on

2020-09-14

Participant Flow

This study was conducted at 12 centers in the European Union (France, Germany, Spain, and the United Kingdom), the United States, and Canada. Of the 54 subjects screened, 47 subjects were enrolled.

The study consisted of a standard of care rituximab-chemotherapy Run-in Period of approximately 21 weeks, a 12- to 16-week blinatumomab Treatment Period, a 30-day safety follow-up, and a Long-term Follow-up Period up to 1 year from the first dose of blinatumomab, or until participant death, whichever occurred first.

Participant milestones

Participant milestones
Measure	Blinatumomab Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Pre-Study Run-In Period STARTED	47
Pre-Study Run-In Period COMPLETED	30
Pre-Study Run-In Period NOT COMPLETED	17
Between Run-In and Treatment Periods STARTED	30
Between Run-In and Treatment Periods COMPLETED	28
Between Run-In and Treatment Periods NOT COMPLETED	2
Treatment Period STARTED	28
Treatment Period Started Cycle 1	28
Treatment Period Started Cycle 2	11
Treatment Period COMPLETED	25
Treatment Period NOT COMPLETED	3
Long Term Follow-Up Period STARTED	28
Long Term Follow-Up Period COMPLETED	26
Long Term Follow-Up Period NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Blinatumomab Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Pre-Study Run-In Period Protocol-specified criteria	11
Pre-Study Run-In Period Death	1
Pre-Study Run-In Period Withdrawal by Subject	5
Between Run-In and Treatment Periods Protocol-specified criteria	2
Treatment Period Disease Progression	1
Treatment Period Withdrawal by Subject	1
Treatment Period Adverse Event	1
Long Term Follow-Up Period Death	2

Baseline Characteristics

Safety and Efficacy of Blinatumomab in Adults With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blinatumomab n=28 Participants Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Age, Continuous	60.2 years STANDARD_DEVIATION 11.1 • n=99 Participants
Age, Customized < 65 years	18 Participants n=99 Participants
Age, Customized >=65 years	10 Participants n=99 Participants
Age, Customized <75 years	25 Participants n=99 Participants
Age, Customized >=75 years	3 Participants n=99 Participants
Sex: Female, Male Female	18 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race/Ethnicity, Customized Asian	1 Participants n=99 Participants
Race/Ethnicity, Customized Black and African American	2 Participants n=99 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race/Ethnicity, Customized White	21 Participants n=99 Participants
Race/Ethnicity, Customized Other	4 Participants n=99 Participants
Disease Stage at Time of Diagnosis Stage I	0 Participants n=99 Participants
Disease Stage at Time of Diagnosis Stage IE	1 Participants n=99 Participants
Disease Stage at Time of Diagnosis Stage II	0 Participants n=99 Participants
Disease Stage at Time of Diagnosis Stage III	5 Participants n=99 Participants
Disease Stage at Time of Diagnosis Stage IV	22 Participants n=99 Participants
International Prognostic Index Score at Diagnosis Score 2	2 Participants n=99 Participants
International Prognostic Index Score at Diagnosis Score 3	17 Participants n=99 Participants
International Prognostic Index Score at Diagnosis Score 4	7 Participants n=99 Participants
International Prognostic Index Score at Diagnosis Score 5	2 Participants n=99 Participants

PRIMARY outcome

Timeframe: From the start of first infusion of IP to 30 days after the end of last infusion of IP; median (min, max) treatment duration was 56 (16, 84) days

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Blinatumomab n=28 Participants Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Participants With Treatment-Emergent (Blinatumomab) Adverse Events TEAE	28 Participants
Participants With Treatment-Emergent (Blinatumomab) Adverse Events TEAE severity grade >=3	11 Participants
Participants With Treatment-Emergent (Blinatumomab) Adverse Events TEAE severity grade >=4	5 Participants
Participants With Treatment-Emergent (Blinatumomab) Adverse Events Serious TEAE	7 Participants
Participants With Treatment-Emergent (Blinatumomab) Adverse Events TEAE leading to interruption of IP	3 Participants
Participants With Treatment-Emergent (Blinatumomab) Adverse Events Serious TEAE leading to interruption of IP	2 Participants
Participants With Treatment-Emergent (Blinatumomab) Adverse Events TEAE leading to discontinuation of IP	2 Participants
Participants With Treatment-Emergent (Blinatumomab) Adverse Events Serious TEAE leading to discontinuation of IP	1 Participants
Participants With Treatment-Emergent (Blinatumomab) Adverse Events Fatal TEAEs	0 Participants

PRIMARY outcome

Timeframe: From the start of first infusion of IP to 30 days after the end of last infusion of IP; median (min, max) treatment duration was 56 (16, 84) days

Population: Full analysis set

Overall incidence and severity of treatment-emergent adverse events deemed by investigators to be related to blinatumomab treatment. Severity was graded by investigators according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and based on the scale: Grade 1 = Mild - transient or mild discomfort; Grade 2 = Moderate - mild to moderate limitation in activity, assistance may be needed; minimal medical intervention required; Grade 3 = Severe - marked limitation in activity, assistance usually required; medical intervention required, hospitalization is possible; Grade 4 = Life threatening - extreme limitation in activity, assistance required; medical intervention, hospitalization or hospice care probable; Grade 5 = death.

Outcome measures

Outcome measures
Measure	Blinatumomab n=28 Participants Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Participants With Treatment-Emergent Adverse Events Related to Blinatumomab Treatment Treatment-related TEAE	23 Participants
Participants With Treatment-Emergent Adverse Events Related to Blinatumomab Treatment Related TEAE severity grade >=3	9 Participants
Participants With Treatment-Emergent Adverse Events Related to Blinatumomab Treatment Related TEAE severity grade >=4	3 Participants
Participants With Treatment-Emergent Adverse Events Related to Blinatumomab Treatment Related Serious TEAE	5 Participants
Participants With Treatment-Emergent Adverse Events Related to Blinatumomab Treatment Related TEAE leading to interruption of IP	3 Participants
Participants With Treatment-Emergent Adverse Events Related to Blinatumomab Treatment Related Serious TEAE leading to interruption of IP	2 Participants
Participants With Treatment-Emergent Adverse Events Related to Blinatumomab Treatment Related TEAE leading to discontinuation of IP	2 Participants
Participants With Treatment-Emergent Adverse Events Related to Blinatumomab Treatment Related Serious TEAE leading to discon of IP	1 Participants
Participants With Treatment-Emergent Adverse Events Related to Blinatumomab Treatment Related and Fatal TEAEs	0 Participants

SECONDARY outcome

Timeframe: Cycle 1: Day 78 (3 weeks following end of Cycle 1 IP treatment) Treatment Period: Either the Cycle 1 timeframe or approximately Day 128 (3 weeks after Cycle 2 ended) for participants who completed Cycle 2

Population: Full Analysis Set

Tumor response assessment was performed by a central reader according to modified Lugano classification using PET/CT scan. Overall objective response rate (ORR) is the percentage of participants with a best overall response of complete metabolic response (CMR) or partial metabolic response (PMR). CMR: a score of 1 (no uptake above background), 2 (uptake \</=mediastinum), or 3 (uptake \<mediastinum but \</=liver) with/without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PMR: a score 4 (uptake moderately greater than \[\>\] liver) or 5 (uptake markedly \>liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline.

Outcome measures

Outcome measures
Measure	Blinatumomab n=28 Participants Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Overall Objective Response Rate (ORR) Expressed as the Percentage of Participants Achieving Complete Metabolic Response (CMR) and Partial Metabolic Response (PMR) Using Lugano 2014 Criteria During Cycle 1 and During Treatment Period Cycle 1	89.3 percentage of participants Interval 71.8 to 97.7
Overall Objective Response Rate (ORR) Expressed as the Percentage of Participants Achieving Complete Metabolic Response (CMR) and Partial Metabolic Response (PMR) Using Lugano 2014 Criteria During Cycle 1 and During Treatment Period Entire Treatment Period	92.9 percentage of participants Interval 76.5 to 99.1

SECONDARY outcome

Timeframe: The median (range) follow-up time was 11.5 (8.2, 14.5) months

Population: Responder Analysis Set includes all participants in the FAS that achieve objective response (CR or PR as per the Lugano classification) on the PET/CT scan.

Duration of response was calculated only for responders during cycle 1. For participants who had CR or PR on the PET/CT scan at the end of the run-in period, response was measured from the start of blinatumomab treatment. For participants who had stable disease at the end of the run-in period, duration was calculated from documentation of the first assessment of either PR or CR on blinatumomab. Progression was defined as the first diagnosis of progressive metabolic response/progressive disease based on PET/CT scan per central or investigator review during the treatment period or relapse based on clinical tumor assessment during the long-term follow up period. Response duration was calculated until the start of new anti-tumor treatment (excluding any stem cell transplantation), PD, or death, whichever was the earliest event. Participants who did not have new anti-tumor treatment (excluding stem cell transplantation), PD, or death were censored at the last tumor assessment date.

Outcome measures

Outcome measures
Measure	Blinatumomab n=25 Participants Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Kaplan-Meier Estimates for Duration of Response	NA months Could not be estimated due to the low number of events

SECONDARY outcome

Population: Full Analysis Set

Tumor response assessment was performed by a central reader according to modified Lugano classification using PET/CT scan. CMR: a score of 1 (no uptake above background), 2 (uptake \</=mediastinum), or 3 (uptake \<mediastinum but \</=liver) with/without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology.

Outcome measures

Outcome measures
Measure	Blinatumomab n=28 Participants Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Complete Response Rate Expressed as the Percentage of Participants Achieving Complete Metabolic Response (CMR) Using Lugano 2014 Criteria During Cycle 1 and During Treatment Period Cycle 1	85.7 percentage of participants Interval 67.3 to 96.0
Complete Response Rate Expressed as the Percentage of Participants Achieving Complete Metabolic Response (CMR) Using Lugano 2014 Criteria During Cycle 1 and During Treatment Period Entire Treatment Period	89.3 percentage of participants Interval 71.8 to 97.7

SECONDARY outcome

Timeframe: The median (range) follow-up time was 12.0 (10.7, 14.5) months.

Population: Full analysis set (FAS)

OS was calculated as the time from the date of first IP infusion until death due to any cause. Participants who are alive at the date that triggers the analysis were censored at the date last known to be alive. Months were calculated as days from the first dose date of blinatumomab to death/censor date, divided by 30.5.

Outcome measures

Outcome measures
Measure	Blinatumomab n=28 Participants Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Kaplan-Meier Estimates for Overall Survival (OS) From First Dose of Blinatumomab	NA months Could not be estimated due to the low number of events

SECONDARY outcome

Timeframe: The median (range) follow-up time was 12.0 (8.2, 14.5)

Population: Full analysis set (FAS)

PFS was calculated as the time from the date of first IP infusion until the date of diagnosis of progression of DLBCL or the date of death, whichever was the earliest. The diagnosis of progression of DLBCL was defined as the first diagnosis of progressive metabolic response/progressive disease based on PET/CT scan per central or investigator review during the treatment period or relapse based on clinical tumor assessment during the long-term follow up period. Participants who were alive and did not have progression were censored at the last evaluable non-missing tumor assessment date prior to the analysis trigger date.

Outcome measures

Outcome measures
Measure	Blinatumomab n=28 Participants Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Kaplan-Meier Estimates for Progression Free Survival (PFS) From First Dose of Blinatumomab	NA months Could not be estimated due to the low number of events

SECONDARY outcome

Timeframe: Day 1 up to 14.5 months

Population: Full Analysis Set (FAS)

Percentage of participants who had HSCT during the Long Term Follow-Up Period.

Outcome measures

Outcome measures
Measure	Blinatumomab n=28 Participants Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Percentage of Participants Who Had Hematopoietic Stem Cell Transplantation (HSCT)	3.6 percentage of participants Interval 0.1 to 18.3

SECONDARY outcome

Timeframe: Day 2 at least 24 hours after blinatumomab was started and on Day 9 and Day 16 at least 24 hours after blinatumomab dose was increased in the cycle

Population: Pharmacokinetic Analysis Set: participants who received any infusion of blinatumomab and had at least one PK sample collected

The steady-state serum concentration (Css), summarized as the observed concentrations collected after at least 10 hours after the start of continuous IV infusion. PK blood samples were analyzed in a central lab.

Outcome measures

Outcome measures
Measure	Blinatumomab n=28 Participants Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Pharmacokinetics (PK) Results for Blinatumomab: Steady-State Concentrations at Week 1, Week 2 and Week 3 for Cycle 1 Cycle 1 Week 1: 9 mcg/day	288 pg/mL Standard Deviation 289
Pharmacokinetics (PK) Results for Blinatumomab: Steady-State Concentrations at Week 1, Week 2 and Week 3 for Cycle 1 Cycle 1 Week 2: 28 mcg/day	795 pg/mL Standard Deviation 280
Pharmacokinetics (PK) Results for Blinatumomab: Steady-State Concentrations at Week 1, Week 2 and Week 3 for Cycle 1 Cycle 1 Week 3: 112 mcg/day	3160 pg/mL Standard Deviation 782

SECONDARY outcome

Timeframe: Day 2 at least 24 hours after blinatumomab was started and on Day 9 and Day 16 at least 24 hours after blinatumomab dose was increased in the cycle

Population: Pharmacokinetic Analysis Set: participants who received any infusion of blinatumomab and had at least one PK sample collected

PK blood samples were analyzed in a central lab.

Outcome measures

Outcome measures
Measure	Blinatumomab n=28 Participants Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Pharmacokinetics (PK) Results for Blinatumomab: Clearance for Cycle 1	1.61 L/Hour Standard Deviation 0.496

Adverse Events

Blinatumomab

Serious events: 7 serious events

Other events: 26 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Blinatumomab n=28 participants at risk Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Blood and lymphatic system disorders Neutropenia	3.6% 1/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
General disorders Pyrexia	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Infections and infestations Bacteraemia	3.6% 1/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Infections and infestations Pneumonia	3.6% 1/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Infections and infestations Sepsis	3.6% 1/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Nervous system disorders Aphasia	3.6% 1/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Nervous system disorders Neurotoxicity	3.6% 1/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.

Other adverse events

Other adverse events
Measure	Blinatumomab n=28 participants at risk Blinatumomab was administered as a continuous intravenous (IV) infusion. Cycle 1 was 12 weeks (84 days) in duration with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, 112 µg/day for 6 weeks, followed by a 4-week treatment free time. An optional 4-week Cycle 2 of blinatumomab was available for participants whose disease did not progress, with step dosing of 9 µg/day for 7 days, 28 µg/day for 7 days, and 112 µg/day for 14 days. There was a safety follow-up for 30 days. And a long-term follow-up of up to 8 months for a maximum of 1 year from first dose of blinatumomab or until participant death.
Blood and lymphatic system disorders Anaemia	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Blood and lymphatic system disorders Neutropenia	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Gastrointestinal disorders Constipation	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Gastrointestinal disorders Diarrhoea	14.3% 4/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Gastrointestinal disorders Dry mouth	10.7% 3/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Gastrointestinal disorders Nausea	17.9% 5/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Gastrointestinal disorders Vomiting	10.7% 3/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
General disorders Asthenia	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
General disorders Chills	10.7% 3/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
General disorders Fatigue	28.6% 8/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
General disorders Pyrexia	35.7% 10/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Immune system disorders Cytokine release syndrome	17.9% 5/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Infections and infestations Upper respiratory tract infection	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Investigations Lymphocyte count decreased	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Investigations Neutrophil count decreased	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Investigations Platelet count decreased	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Investigations White blood cell count decreased	10.7% 3/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Metabolism and nutrition disorders Hypophosphataemia	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Musculoskeletal and connective tissue disorders Arthralgia	17.9% 5/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Musculoskeletal and connective tissue disorders Back pain	17.9% 5/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Musculoskeletal and connective tissue disorders Flank pain	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Musculoskeletal and connective tissue disorders Muscular weakness	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	10.7% 3/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Musculoskeletal and connective tissue disorders Myalgia	14.3% 4/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Musculoskeletal and connective tissue disorders Neck pain	10.7% 3/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Musculoskeletal and connective tissue disorders Pain in extremity	17.9% 5/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Nervous system disorders Ataxia	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Nervous system disorders Dizziness	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Nervous system disorders Headache	25.0% 7/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Nervous system disorders Paraesthesia	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Nervous system disorders Tremor	35.7% 10/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Psychiatric disorders Insomnia	14.3% 4/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Respiratory, thoracic and mediastinal disorders Cough	28.6% 8/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Respiratory, thoracic and mediastinal disorders Dysphonia	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.7% 3/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.7% 3/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Skin and subcutaneous tissue disorders Erythema	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Skin and subcutaneous tissue disorders Pruritus	10.7% 3/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Skin and subcutaneous tissue disorders Rash	7.1% 2/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Vascular disorders Flushing	32.1% 9/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.
Vascular disorders Hypotension	14.3% 4/28 • Mortality is reported for all enrolled participants from enrollment in the Run-in Period to the end of long-term follow-up. Adverse events are reported from the first dose of blinatumomab through 30 days after last dose; median duration of treatment was 56 days. In addition, serious adverse events related to blinatumomab collected during the long-term follow-up period are reported; median time on follow-up was 12 months. All-cause mortality data are reported for all participants who enrolled in the Run-in Period. Adverse events are reported for all participants who received at least one dose of blinatumomab in the Treatment Period. During the long-term follow-up period, only serious adverse events related to blinatumomab were collected.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

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