Trial Outcomes & Findings for Study to Investigate Intravenous Blinatumomab in Japanese Adult Participants With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL) (NCT NCT06649006)
NCT ID: NCT06649006
Last Updated: 2026-05-13
Results Overview
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment. TEAEs are any events that occurred after the participant received trial treatment. A serious TEAE was defined as any untoward medical occurrence that: was immediately life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was any other medically important serious event. Treatment-related TEAEs were any AEs that could be considered attributable to the trial treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
From first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days
Results posted on
2026-05-13
Participant Flow
Participants were enrolled at 5 trial centers in Japan from 08 January 2025. The primary analysis data is presented based on the data cutoff date of 30 July 2025. The trial is ongoing.
Japanese participants with newly diagnosed Philadelphia -negative B-precursor acute lymphoblastic leukemia (B-ALL) in complete remission (CR)/CR with partial hematologic recovery (CRh) were treated with blinatumomab.
Participant milestones
| Measure |
Evaluable Participants: Blinatumomab
Evaluable participants received blinatumomab up to 28 μg/day as a continuous intravenous infusion (cIV) over 28 days, followed by a 14 day infusion free period. Treatment was given for up to 4 cycles or until disease progression, initiation of alternative therapy if considered more appropriate, or inability to tolerate the trial drug (Cycle length=42 days).
|
Non-evaluable Participants: Blinatumomab
Non-evaluable participants received blinatumomab up to 28 μg/day as a cIV over 28 days, followed by a 14 day infusion free period. Non-evaluable participants discontinued during the first cycle (Cycle length=42 days).
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
1
|
|
Overall Study
Completed Blinatumomab During Cycle 1
|
5
|
0
|
|
Overall Study
Discontinued Blinatumomab Treatment During Cycle 1 Due to AE
|
0
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Evaluable Participants: Blinatumomab
Evaluable participants received blinatumomab up to 28 μg/day as a continuous intravenous infusion (cIV) over 28 days, followed by a 14 day infusion free period. Treatment was given for up to 4 cycles or until disease progression, initiation of alternative therapy if considered more appropriate, or inability to tolerate the trial drug (Cycle length=42 days).
|
Non-evaluable Participants: Blinatumomab
Non-evaluable participants received blinatumomab up to 28 μg/day as a cIV over 28 days, followed by a 14 day infusion free period. Non-evaluable participants discontinued during the first cycle (Cycle length=42 days).
|
|---|---|---|
|
Overall Study
Ongoing in the trial
|
3
|
0
|
Baseline Characteristics
Study to Investigate Intravenous Blinatumomab in Japanese Adult Participants With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL)
Baseline characteristics by cohort
| Measure |
Evaluable Participants: Blinatumomab
n=5 Participants
Evaluable participants received blinatumomab up to 28 μg/day as a continuous intravenous infusion (cIV) over 28 days, followed by a 14 day infusion free period. Treatment was given for up to 4 cycles or until disease progression, initiation of alternative therapy if considered more appropriate, or inability to tolerate the trial drug (Cycle length=42 days).
|
Non-evaluable Participants: Blinatumomab
n=1 Participants
Non-evaluable participants received blinatumomab up to 28 μg/day as a cIV over 28 days, followed by a 14 day infusion free period. Non-evaluable participants discontinued during the first cycle (Cycle length=42 days).
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.0 years
STANDARD_DEVIATION 15.7 • n=1512 Participants
|
54.0 years
STANDARD_DEVIATION NA • n=504 Participants
|
44.0 years
STANDARD_DEVIATION 14.9 • n=2016 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
4 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
6 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
6 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: From first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) daysPopulation: The safety analysis set included all participants that were enrolled and received at least one dose of blinatumomab.
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment. TEAEs are any events that occurred after the participant received trial treatment. A serious TEAE was defined as any untoward medical occurrence that: was immediately life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was any other medically important serious event. Treatment-related TEAEs were any AEs that could be considered attributable to the trial treatment.
Outcome measures
| Measure |
Evaluable Participants: Blinatumomab
n=5 Participants
Evaluable participants received blinatumomab up to 28 μg/day as a continuous intravenous infusion (cIV) over 28 days, followed by a 14 day infusion free period. Treatment was given for up to 4 cycles or until disease progression, initiation of alternative therapy if considered more appropriate, or inability to tolerate the trial drug (Cycle length=42 days).
|
Non-evaluable Participants: Blinatumomab
n=1 Participants
Non-evaluable participants received blinatumomab up to 28 μg/day as a cIV over 28 days, followed by a 14 day infusion free period. Non-evaluable participants discontinued during the first cycle (Cycle length=42 days).
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-related TEAEs
TEAEs
|
5 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-related TEAEs
Serious TEAEs
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-related TEAEs
Treatment-related TEAEs
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) daysPopulation: The safety analysis set included all participants that were enrolled and received at least one dose of blinatumomab.
An AE was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment. TEAEs were any events that occurred after the participant received trial treatment.
Outcome measures
| Measure |
Evaluable Participants: Blinatumomab
n=5 Participants
Evaluable participants received blinatumomab up to 28 μg/day as a continuous intravenous infusion (cIV) over 28 days, followed by a 14 day infusion free period. Treatment was given for up to 4 cycles or until disease progression, initiation of alternative therapy if considered more appropriate, or inability to tolerate the trial drug (Cycle length=42 days).
|
Non-evaluable Participants: Blinatumomab
n=1 Participants
Non-evaluable participants received blinatumomab up to 28 μg/day as a cIV over 28 days, followed by a 14 day infusion free period. Non-evaluable participants discontinued during the first cycle (Cycle length=42 days).
|
|---|---|---|
|
Number of Participants Experiencing Adverse Events of Interest (EOI)
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Cycle 1: Day 1 pre-dose, 2 and 6 hours post-dose on Day 1, Day 2, Day 3, Day 29; Cycle 2: Day 1 pre-dose, and Days 2 and 29; Cycles 3 and 4: Day 1 pre-dose, and Day 29Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Day 1 pre-dose, 2 and 6 hours post-dose on Day 1, Day 2, Day 3, Day 29; Cycle 2: Day 1 pre-dose, and Days 2 and 29; Cycles 3 and 4: Day 1 pre-dose, and Day 29Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1-4: Day 29 (each cycle is 42 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1-4: Day 29 (each cycle is 42 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1-4: Day 29 (each cycle is 42 days)Outcome measures
Outcome data not reported
Adverse Events
Evaluable Participants: Blinatumomab
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Non-evaluable Participants: Blinatumomab
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Evaluable Participants: Blinatumomab
n=5 participants at risk
Evaluable participants received blinatumomab up to 28 μg/day as a continuous intravenous infusion (cIV) over 28 days, followed by a 14 day infusion free period. Treatment was given for up to 4 cycles or until disease progression, initiation of alternative therapy if considered more appropriate, or inability to tolerate the trial drug (Cycle length=42 days).
|
Non-evaluable Participants: Blinatumomab
n=1 participants at risk
Non-evaluable participants received blinatumomab up to 28 μg/day as a cIV over 28 days, followed by a 14 day infusion free period. Non-evaluable participants discontinued during the first cycle (Cycle length=42 days).
|
|---|---|---|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
|
20.0%
1/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
Other adverse events
| Measure |
Evaluable Participants: Blinatumomab
n=5 participants at risk
Evaluable participants received blinatumomab up to 28 μg/day as a continuous intravenous infusion (cIV) over 28 days, followed by a 14 day infusion free period. Treatment was given for up to 4 cycles or until disease progression, initiation of alternative therapy if considered more appropriate, or inability to tolerate the trial drug (Cycle length=42 days).
|
Non-evaluable Participants: Blinatumomab
n=1 participants at risk
Non-evaluable participants received blinatumomab up to 28 μg/day as a cIV over 28 days, followed by a 14 day infusion free period. Non-evaluable participants discontinued during the first cycle (Cycle length=42 days).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
1/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
100.0%
1/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
100.0%
1/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Immune system disorders
Cytokine release syndrome
|
40.0%
2/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
100.0%
1/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
20.0%
1/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Device related infection
|
20.0%
1/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Investigations
Neutrophil count decreased
|
40.0%
2/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Investigations
White blood cell count decreased
|
20.0%
1/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
20.0%
1/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
|
20.0%
1/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
100.0%
1/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
1/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
20.0%
1/5 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/1 • For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
Additional Information
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