Trial Outcomes & Findings for A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia. (NCT NCT02310321)
NCT ID: NCT02310321
Last Updated: 2025-09-02
Results Overview
The MTD was defined as the highest dose of gilteritinib at which the posterior mean of the DLT incidence during Cycle 1 of induction therapy was estimated to be closest to 33%.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
97 participants
Primary outcome timeframe
Day 1 up to the end of Induction period cycle 1 (up to 42 days)
Results posted on
2025-09-02
Participant Flow
Participants with newly diagnosed acute myeloid leukemia (AML) and participants newly diagnosed FMS-like tyrosine kinase-3, FMS-related tyrosine kinase 3 (FLT3)-mutated AML; were enrolled in Phase 1 and Phase 2, respectively.
Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study.
Participant milestones
| Measure |
Phase 1: Dose Evaluation (DEv)
Induction period (IP):
Participants received 120 milligrams (mg) gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 milligrams per square meters per day \[mg/m\^2/day\] on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via intravenous (IV) infusion; in the induction period in cycles (C) 1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period (CP):
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period (MP):
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 2: FLT3-mutated AML
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 8 until blood recovery in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 until blood recovery in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|---|
|
Phase 1(DEv):IP (2 Cycles;42 Days/Cycle)
STARTED
|
3
|
0
|
0
|
|
Phase 1(DEv):IP (2 Cycles;42 Days/Cycle)
COMPLETED
|
2
|
0
|
0
|
|
Phase 1(DEv):IP (2 Cycles;42 Days/Cycle)
NOT COMPLETED
|
1
|
0
|
0
|
|
Phase 1(DEv):CP (3 Cycles;28 Days/Cycle)
STARTED
|
2
|
0
|
0
|
|
Phase 1(DEv):CP (3 Cycles;28 Days/Cycle)
COMPLETED
|
1
|
0
|
0
|
|
Phase 1(DEv):CP (3 Cycles;28 Days/Cycle)
NOT COMPLETED
|
1
|
0
|
0
|
|
Phase 1(DEv):MP(26 Cycles;28 Days/Cycle)
STARTED
|
1
|
0
|
0
|
|
Phase 1(DEv):MP(26 Cycles;28 Days/Cycle)
COMPLETED
|
0
|
0
|
0
|
|
Phase 1(DEv):MP(26 Cycles;28 Days/Cycle)
NOT COMPLETED
|
1
|
0
|
0
|
|
Phase 1(DEx):IP (2 Cycles;42 Days/Cycle)
STARTED
|
0
|
10
|
0
|
|
Phase 1(DEx):IP (2 Cycles;42 Days/Cycle)
COMPLETED
|
0
|
3
|
0
|
|
Phase 1(DEx):IP (2 Cycles;42 Days/Cycle)
NOT COMPLETED
|
0
|
7
|
0
|
|
Phase 1(DEx):CP (3 Cycles;28 Days/Cycle)
STARTED
|
0
|
3
|
0
|
|
Phase 1(DEx):CP (3 Cycles;28 Days/Cycle)
COMPLETED
|
0
|
3
|
0
|
|
Phase 1(DEx):CP (3 Cycles;28 Days/Cycle)
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase 1(DEx):MP(26 Cycles;28 Days/Cycle)
STARTED
|
0
|
3
|
0
|
|
Phase 1(DEx):MP(26 Cycles;28 Days/Cycle)
COMPLETED
|
0
|
0
|
0
|
|
Phase 1(DEx):MP(26 Cycles;28 Days/Cycle)
NOT COMPLETED
|
0
|
3
|
0
|
|
Phase 2:IP(2 Cycles;up to 56 Days/Cycle)
STARTED
|
0
|
0
|
84
|
|
Phase 2:IP(2 Cycles;up to 56 Days/Cycle)
COMPLETED
|
0
|
0
|
62
|
|
Phase 2:IP(2 Cycles;up to 56 Days/Cycle)
NOT COMPLETED
|
0
|
0
|
22
|
|
Phase 2:CP(4 Cycles;up to 28 Days/Cycle)
STARTED
|
0
|
0
|
57
|
|
Phase 2:CP(4 Cycles;up to 28 Days/Cycle)
COMPLETED
|
0
|
0
|
42
|
|
Phase 2:CP(4 Cycles;up to 28 Days/Cycle)
NOT COMPLETED
|
0
|
0
|
15
|
|
Phase 2:MP(26 Cycles; 28 Days/Cycle)
STARTED
|
0
|
0
|
46
|
|
Phase 2:MP(26 Cycles; 28 Days/Cycle)
COMPLETED
|
0
|
0
|
23
|
|
Phase 2:MP(26 Cycles; 28 Days/Cycle)
NOT COMPLETED
|
0
|
0
|
23
|
Reasons for withdrawal
| Measure |
Phase 1: Dose Evaluation (DEv)
Induction period (IP):
Participants received 120 milligrams (mg) gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 milligrams per square meters per day \[mg/m\^2/day\] on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via intravenous (IV) infusion; in the induction period in cycles (C) 1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period (CP):
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period (MP):
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 2: FLT3-mutated AML
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 8 until blood recovery in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 until blood recovery in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|---|
|
Phase 1(DEv):IP (2 Cycles;42 Days/Cycle)
Miscellaneous
|
1
|
0
|
0
|
|
Phase 1(DEv):CP (3 Cycles;28 Days/Cycle)
Miscellaneous
|
1
|
0
|
0
|
|
Phase 1(DEv):MP(26 Cycles;28 Days/Cycle)
Miscellaneous
|
1
|
0
|
0
|
|
Phase 1(DEx):IP (2 Cycles;42 Days/Cycle)
Adverse Event
|
0
|
1
|
0
|
|
Phase 1(DEx):IP (2 Cycles;42 Days/Cycle)
Miscellaneous
|
0
|
4
|
0
|
|
Phase 1(DEx):IP (2 Cycles;42 Days/Cycle)
There is no CR, CRp, or CRi after 2 Cycles of Therapy
|
0
|
1
|
0
|
|
Phase 1(DEx):IP (2 Cycles;42 Days/Cycle)
Disease Relapse
|
0
|
1
|
0
|
|
Phase 1(DEx):MP(26 Cycles;28 Days/Cycle)
Micellaneous
|
0
|
3
|
0
|
|
Phase 2:IP(2 Cycles;up to 56 Days/Cycle)
Miscellaneous
|
0
|
0
|
2
|
|
Phase 2:IP(2 Cycles;up to 56 Days/Cycle)
Disease Relapse
|
0
|
0
|
2
|
|
Phase 2:IP(2 Cycles;up to 56 Days/Cycle)
Physician Decision
|
0
|
0
|
6
|
|
Phase 2:IP(2 Cycles;up to 56 Days/Cycle)
Withdrawal by Subject
|
0
|
0
|
4
|
|
Phase 2:IP(2 Cycles;up to 56 Days/Cycle)
Lack of Efficacy
|
0
|
0
|
3
|
|
Phase 2:IP(2 Cycles;up to 56 Days/Cycle)
Death
|
0
|
0
|
3
|
|
Phase 2:IP(2 Cycles;up to 56 Days/Cycle)
Adverse Event
|
0
|
0
|
2
|
|
Phase 2:CP(4 Cycles;up to 28 Days/Cycle)
Miscellaneous
|
0
|
0
|
7
|
|
Phase 2:CP(4 Cycles;up to 28 Days/Cycle)
Disease Relapse
|
0
|
0
|
4
|
|
Phase 2:CP(4 Cycles;up to 28 Days/Cycle)
Physician Decision
|
0
|
0
|
4
|
|
Phase 2:MP(26 Cycles; 28 Days/Cycle)
Disease relapse
|
0
|
0
|
11
|
|
Phase 2:MP(26 Cycles; 28 Days/Cycle)
Miscellaneous
|
0
|
0
|
2
|
|
Phase 2:MP(26 Cycles; 28 Days/Cycle)
Adverse Event
|
0
|
0
|
3
|
|
Phase 2:MP(26 Cycles; 28 Days/Cycle)
Death
|
0
|
0
|
1
|
|
Phase 2:MP(26 Cycles; 28 Days/Cycle)
Physician Decision
|
0
|
0
|
6
|
Baseline Characteristics
A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.
Baseline characteristics by cohort
| Measure |
Phase 1: Dose Evaluation (DEv)
n=3 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
n=10 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 2: FLT3-mutated AML
n=84 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 8 until blood recovery in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 until blood recovery in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.3 Years
STANDARD_DEVIATION 14 • n=5 Participants
|
49.9 Years
STANDARD_DEVIATION 15 • n=7 Participants
|
51 Years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
50.8 Years
STANDARD_DEVIATION 14.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to the end of Induction period cycle 1 (up to 42 days)Population: Dose-Determining Analysis Set (DDAS) Phase 1 part: Participants who received more than 80% of the intended dose of gilteritinib and safety was adequately assessed during DLT assessment period specified in each part were included.
The MTD was defined as the highest dose of gilteritinib at which the posterior mean of the DLT incidence during Cycle 1 of induction therapy was estimated to be closest to 33%.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=3 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 1 Part: Maximum Tolerated Dose (MTD) of Gilteritinib
|
NA miligram (mg)
The posterior mean of DLT incidence estimated was lower than the pre-specified value of 33%, therefore, MTD was not reached.
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to the end of Induction period cycle 1 (up to 42 days)Population: Participants in the DDAS.
RED was the recommended dose used in Phase 2 of the study that was decided by the sponsor's responsible person by comprehensively assessing the data obtained from the study.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=3 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 1 Part: Recommended Expansion Dose (RED) of Gilteritinib
|
120 mg
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to the end of Consolidation Cycle 1 (approximately up to 4 months)Population: Participants in the DDAS.
DLTs were defined as: Any Grade ≥ 3 non-hematologic or extramedullary toxicity with the following exceptions: * Anorexia or fatigue * Grade 3 nausea and/or vomiting if participant did not require tube feeding or total parenteral nutrition, or diarrhea if the events did not require or prolong hospitalization that could be managed to grade ≤ 2 with standard antiemetic or antidiarrheal medications used at prescribed dose within 7 days of onset. * Grade 3 mucositis that resolved to Grade ≤ 2 within 7 days of onset, fever with neutropenia, with or without infection, infection * Grade 4 peripheral neutrophil count \< 500/cubic millimeters (mm\^3) * Platelet count \< 20,000/mm\^3 due to bone marrow hypoplasia * Grade ≥ 3 platelet count \< 50,000/mm\^3 accompanying bleeding * Grade 4 platelet count \< 25,000/mm\^3 requiring platelet transfusion DLT was assessed until cycle 1 of dose evaluation induction period and until cycle 1 of dose expansion consolidation period.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=3 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
n=10 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 1 Part: Number of Participants With Dose Limiting Toxicities (DLTs) of Gilteritinib
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years)Population: SAF
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE included both serious and non-serious AEs. TEAE for Phase 1 was defined as an AE observed after the date of first dose until 30 days after the last dose.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=3 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
n=10 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 1 Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
3 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: From the date of first dose up to the start of Consolidation (approximately up to 4 months)Population: Participants in the Full Analysis Set (FAS) Phase 2 part: Participants who received at least 1 dose of study drug and had at least one post-baseline bone marrow assessment were included.
Percentage of participants with CR was reported. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3, bone marrow blasts \< 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=82 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: Complete Remission (CR) Rate: Induction Period
|
50 Percentage of participants
Interval 40.4 to 59.6
|
—
|
SECONDARY outcome
Timeframe: Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1Population: Pharmacokinetics Analysis Set (PKAS): Participants who received the study drug, from whom samples for drug concentration measurement were collected for at least 1 time-point after the study drug administration, and from whom drug concentration measurement was obtained were included. PKAS with available data analyzed.
Cmax was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=3 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
n=10 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 1 Part: Maximum Concentration (Cmax) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Induction Period
|
246 nanograms per milliliter (ng/mL)
Standard Deviation 154
|
132 nanograms per milliliter (ng/mL)
Standard Deviation 27.5
|
|
Phase 1 Part: Maximum Concentration (Cmax) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Consolidation period
|
133 nanograms per milliliter (ng/mL)
Standard Deviation NA
Since there were less than 3 participants analyzed, SD was not calculated nor reported.
|
73.5 nanograms per milliliter (ng/mL)
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1Population: PKAS with available data analyzed.
Tmax was derived from the PK samples collected.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=3 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
n=10 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 1 Part: Time to Attain Cmax (Tmax) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Induction period
|
3.93 hours
Interval 3.82 to 6.13
|
5.77 hours
Interval 3.83 to 9.77
|
|
Phase 1 Part: Time to Attain Cmax (Tmax) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Consolidation period
|
2.94 hours
Interval 1.85 to 4.03
|
4.32 hours
Interval 3.9 to 9.7
|
SECONDARY outcome
Timeframe: Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1Population: PKAS with available data analyzed.
AUC24 was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=3 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
n=10 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 1 Part: Area Under Plasma Concentration-time Curve From Time 0 to 24 (AUC24) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Induction period
|
3880 ng*hr/mL
Standard Deviation 2530
|
2210 ng*hr/mL
Standard Deviation 567
|
|
Phase 1 Part: Area Under Plasma Concentration-time Curve From Time 0 to 24 (AUC24) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Consolidation period
|
2110 ng*hr/mL
Standard Deviation NA
Since there were less than 3 participants analyzed, SD was not calculated nor reported.
|
1160 ng*hr/mL
Standard Deviation 204
|
SECONDARY outcome
Timeframe: Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1Population: PKAS with available data analyzed.
AUClast was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=3 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
n=10 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 1 Part: Area Under The Concentration-Time Curve From The Time Zero to The Last Measurable Concentration (AUClast) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Induction period
|
3830 ng*hr/mL
Standard Deviation 2520
|
2190 ng*hr/mL
Standard Deviation 552
|
|
Phase 1 Part: Area Under The Concentration-Time Curve From The Time Zero to The Last Measurable Concentration (AUClast) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Consolidation period
|
2090 ng*hr/mL
Standard Deviation NA
Since there were less than 3 participants analyzed, SD was not calculated nor reported.
|
1150 ng*hr/mL
Standard Deviation 202
|
SECONDARY outcome
Timeframe: Induction period: Pre-dose on Cycle 1 Day 8, 11, and 17 Consolidation period: Pre-dose on Cycle 1 Day 6 and 15Population: PKAS with available data analyzed.
Ctrough is the plasma concentration prior to drug administration. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=3 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
n=9 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 1 Part: Plasma Trough Concentration (Ctrough) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Induction period: Cycle 1 day 8
|
245 ng/mL
Standard Deviation 144
|
245 ng/mL
Standard Deviation 77.7
|
|
Phase 1 Part: Plasma Trough Concentration (Ctrough) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Induction period: Cycle 1 day 11
|
283 ng/mL
Standard Deviation 183
|
417 ng/mL
Standard Deviation 203
|
|
Phase 1 Part: Plasma Trough Concentration (Ctrough) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Induction period: Cycle 1 day 17
|
393 ng/mL
Standard Deviation 252
|
455 ng/mL
Standard Deviation 143
|
|
Phase 1 Part: Plasma Trough Concentration (Ctrough) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Consolidation period: Cycle 1 day 6
|
194 ng/mL
Standard Deviation NA
Since there were less than 3 participants analyzed, SD was not calculated nor reported.
|
159 ng/mL
Standard Deviation 12.1
|
|
Phase 1 Part: Plasma Trough Concentration (Ctrough) of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Consolidation period: Cycle 1 day 15
|
285 ng/mL
Standard Deviation NA
Since there were less than 3 participants analyzed, SD was not calculated nor reported.
|
171 ng/mL
Standard Deviation 154
|
SECONDARY outcome
Timeframe: Induction period: Predose on Cycle 1 Day 1, 3, and 8 Consolidation period: Predose on Cycle 1 Day 2 and 6Population: PKAS with available data analyzed.
Ctrough is the plasma concentration prior to drug administration. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=3 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
n=9 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 1 Part: Plasma Trough Concentration of Cytarabine Concomitant With Gilteritinib With Induction and Consolidation Period
Induction period: Cycle 1 Day 1
|
0 ng/mL
Standard Deviation NA
Since the mean concentration of pre-dose of Cytarabine is zero, therefore, SD was not estimated.
|
0 ng/mL
Standard Deviation NA
Since the mean concentration of pre-dose of Cytarabine is zero, therefore, SD was not estimated.
|
|
Phase 1 Part: Plasma Trough Concentration of Cytarabine Concomitant With Gilteritinib With Induction and Consolidation Period
Induction period: Cycle 1 Day 3
|
34.9 ng/mL
Standard Deviation 14.5
|
210 ng/mL
Standard Deviation 417
|
|
Phase 1 Part: Plasma Trough Concentration of Cytarabine Concomitant With Gilteritinib With Induction and Consolidation Period
Induction period: Cycle 1 Day 8
|
58.8 ng/mL
Standard Deviation 8.67
|
110 ng/mL
Standard Deviation 107
|
|
Phase 1 Part: Plasma Trough Concentration of Cytarabine Concomitant With Gilteritinib With Induction and Consolidation Period
Consolidation period: Cycle 1 Day 2
|
4.87 ng/mL
Standard Deviation NA
Since there were less than 3 participants analyzed, SD was not calculated nor reported.
|
9.39 ng/mL
Standard Deviation 2.19
|
|
Phase 1 Part: Plasma Trough Concentration of Cytarabine Concomitant With Gilteritinib With Induction and Consolidation Period
Consolidation period: Cycle 1 Day 6
|
7.09 ng/mL
Standard Deviation NA
Since there were less than 3 participants analyzed, SD was not calculated nor reported.
|
11.8 ng/mL
Standard Deviation 1.91
|
SECONDARY outcome
Timeframe: Induction period : Predose on Cycle 1 Day 15 and 21 Consolidation period: Predose on Cycle 1 Day 8 and 15Population: PKAS with available data analyzed.
Ctrough is the plasma concentration prior to drug administration.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=83 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: Plasma Trough Concentration of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Induction Period: Cycle 1 Day 15
|
522 ng/mL
Standard Deviation 331
|
—
|
|
Phase 2 Part: Plasma Trough Concentration of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Induction Period: Cycle 1 Day 21
|
647 ng/mL
Standard Deviation 518
|
—
|
|
Phase 2 Part: Plasma Trough Concentration of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Consolidation Period: Cycle 1 Day 8
|
244 ng/mL
Standard Deviation 152
|
—
|
|
Phase 2 Part: Plasma Trough Concentration of Gilteritinib Concomitant With Induction and Consolidation Chemotherapy
Consolidation Period: Cycle 1 Day 15
|
375 ng/mL
Standard Deviation 249
|
—
|
SECONDARY outcome
Timeframe: From the date of first dose up to the date of death (maximum duration: approximately 4.4 years)Population: Time-to-Event-FAS (TTE-FAS): All participants who received at least 1 dose of gilteritinib with or without postbaseline bone marrow assessments.
Overall survival (OS) was defined as the time from the date of first dose of day 1 to the date of death due to any cause. Participants still alive or lost to follow up was censored at the time they were last known to be alive. Kaplan-Meier (KM) estimate was used for analysis.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=84 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: Overall Survival (OS)
|
48.2 Months
Interval 45.1 to
The upper limit of the confidence interval of the median survival time was not estimable, since the upper limit of the confidence interval of the Kaplan-Meier plot did not reach 50% survival due to insufficient number of events.
|
—
|
SECONDARY outcome
Timeframe: From the date of first dose up to the date of documented relapse, treatment failure or death from any cause (maximum duration: approximately 4.4 years)Population: TTE-FAS
Event-free survival (EFS): time from date of first dose of study regimen until date of documented relapse, treatment failure or death from any cause, whichever occurred first. KM estimate was used for analysis. Relapse: reappearance of leukemic blasts in peripheral blood (\>2%)/≥ 5% blasts in bone marrow aspirate (BMA)/reappearance of significant numbers of peripheral blasts and an increase in percentage of blasts in BMA to \> 25%. Treatment failure: participants who failed to achieve composite complete remission (CRc) or who discontinued treatment due to "lack of efficacy" without previous response. CRc: rate of all complete \& incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi). CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (\< 100,000/mm\^3). CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (\< 1,000/mm\^3). CR: defined in outcome measure #5.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=84 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: Event Free Survival (EFS)
|
25.0 Months
Interval 11.3 to 48.2
|
—
|
SECONDARY outcome
Timeframe: From the date of achievement of first CRc up to the date of documented relapse or death from any cause (maximum duration: approximately 3.9 years)Population: FAS
Relapse-free survival (RFS): time from date of achievement of first CRc until relapse or death from any cause. KM estimate was used for analysis. Relapse: reappearance of leukemic blasts in peripheral blood (\>2%)/≥ 5% blasts in bone marrow aspirate (BMA)/reappearance of significant numbers of peripheral blasts and an increase in percentage of blasts in BMA to \> 25%. CRc: rate of all complete \& incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi). CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (\< 100,000/mm\^3). CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (\< 1,000/mm\^3). CR: morphologically leukemia-free state at post-baseline visit, having neutrophil count of ≥ 1,000/mm\^3 and platelet count of ≥ 100,000/mm\^3, bone marrow blasts \< 5%. No evidence of Auer rods \& extramedullary leukemia. Blast counts in peripheral blood was ≤ 2%.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=82 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: Relapse Free Survival (RFS)
|
27.8 Months
Interval 17.4 to 39.8
|
—
|
SECONDARY outcome
Timeframe: CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years)Population: The analysis population consisted of FAS participants, regardless of whether they proceeded to consolidation or maintenance. CR rate after consolidation included participants from induction through consolidation and CR rate after maintenance included participants from induction through maintenance.
Percentage of participants with CR was reported. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm\^3 and platelet count of ≥ 100,000/mm\^3, bone marrow blasts \< 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. Derived response assessment after the consolidation period refers to the best response from the start of treatment in the induction period until the end of the consolidation period and for the maintenance period refers to the best response from the start of treatment in the induction period until the end of the maintenance period.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=82 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: CR Rate After Consolidation and Maintenance Period
After consolidation period
|
63.4 Percentage of participants
Interval 52.0 to 73.8
|
—
|
|
Phase 2 Part: CR Rate After Consolidation and Maintenance Period
After maintenance period
|
63.4 Percentage of participants
Interval 52.0 to 73.8
|
—
|
SECONDARY outcome
Timeframe: IP: From date of first dose up to end of period (approximately 1.4 years), CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years)Population: The analysis population consisted of FAS participants, regardless of whether they proceeded to induction, consolidation or maintenance. CR rate after: induction included participants from start of treatment through induction; consolidation included participants from induction through consolidation and maintenance included participants from induction through maintenance.
CR% without MRD reported. CR rate without MRD after each treatment therapy was defined similarly as CR rate after each treatment therapy. Responders achieve that the best response is CR and MRD status was negative. CR was defined as a morphologically leukemia-free state, having a neutrophil count of ≥ 1,000/mm\^3 and platelet count of ≥ 100,000/mm\^3, bone marrow blasts \< 5%. No evidence of Auer rods and extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. Derived response assessment after the IP refers to the best response from the start of treatment in the IP until the end of the IP, after CP refers to the best response from the start of treatment in the IP until the end of the CP and for the MP refers to the best response from the start of treatment in the IP until the end of the MP.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=82 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: CR Rate Without Minimal Residual Disease (MRD) After Each Treatment Therapy Period
After Induction Period
|
18.3 Percentage of participants
Interval 10.6 to 28.4
|
—
|
|
Phase 2 Part: CR Rate Without Minimal Residual Disease (MRD) After Each Treatment Therapy Period
After Consolidation Period
|
35.4 Percentage of participants
Interval 25.1 to 46.7
|
—
|
|
Phase 2 Part: CR Rate Without Minimal Residual Disease (MRD) After Each Treatment Therapy Period
After Maintenance Period
|
35.4 Percentage of participants
Interval 25.1 to 46.7
|
—
|
SECONDARY outcome
Timeframe: IP: From date of first dose up to end of period (approximately 1.4 years), CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years)Population: The analysis population consisted of FAS participants, regardless of whether they proceeded to induction, consolidation or maintenance. CR rate after: induction included participants from start of treatment through induction; consolidation included participants from induction through consolidation and maintenance included participants from induction through maintenance.
Percentage of participants with CRh was reported. CRh was defined as a condition at the post baseline visit, having bone marrow blasts \< 5%, partial hematologic recovery neutrophil count≥ 500/mm\^3 and platelet count ≥ 50,000/mm\^3, no evidence of extramedullary leukemia and could be classified as CR. The blast counts in peripheral blood was ≤ 2%. Derived response assessment after the IP refers to the best response from the start of treatment in the IP until the end of the IP, after CP refers to the best response from the start of treatment in the IP until the end of the CP and for the MP refers to the best response from the start of treatment in the IP until the end of the MP.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=82 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: CR With Partial Hematological Recovery (CRh) Rate After Each Treatment Therapy Period
After Induction Period
|
17.1 Percentage of participants
Interval 9.7 to 27.0
|
—
|
|
Phase 2 Part: CR With Partial Hematological Recovery (CRh) Rate After Each Treatment Therapy Period
After Consolidation Period
|
9.8 Percentage of participants
Interval 4.3 to 18.3
|
—
|
|
Phase 2 Part: CR With Partial Hematological Recovery (CRh) Rate After Each Treatment Therapy Period
After Maintenance Period
|
9.8 Percentage of participants
Interval 4.3 to 18.3
|
—
|
SECONDARY outcome
Timeframe: IP: From date of first dose up to end of period (approximately 1.4 years), CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years)Population: The analysis population consisted of FAS participants, regardless of whether they proceeded to induction, consolidation or maintenance. CR rate after: induction included participants from start of treatment through induction; consolidation included participants from induction through consolidation and maintenance included participants from induction through maintenance.
Percentage of participants with CRc reported. CRc: rate of all complete \& incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recovery (CRi). CRp: met all CR criteria, except unrecovered platelet count (\< 100,000/mm\^3). CRi: met all CR criteria, except unrecovered neutrophil count (\< 1,000/mm\^3). CR: morphologically leukemia-free state, having neutrophil count of ≥ 1,000/mm\^3 and platelet count of ≥ 100,000/mm\^3, bone marrow blasts \< 5%. No evidence of Auer rods \& extramedullary leukemia. Blast counts in peripheral blood was ≤ 2%. Derived response assessment after the IP refers to the best response from the start of treatment in the IP until the end of the IP, after CP refers to the best response from the start of treatment in the IP until the end of the CP and for the MP refers to the best response from the start of treatment in the IP until the end of the MP.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=82 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: Composite CR (CRc) Rate After Each Treatment Therapy Period
After Induction Period
|
86.6 Percentage of participants
Interval 77.3 to 93.1
|
—
|
|
Phase 2 Part: Composite CR (CRc) Rate After Each Treatment Therapy Period
After Consolidation Period
|
87.8 Percentage of participants
Interval 78.7 to 94.0
|
—
|
|
Phase 2 Part: Composite CR (CRc) Rate After Each Treatment Therapy Period
After Maintenance Period
|
87.8 Percentage of participants
Interval 78.7 to 94.0
|
—
|
SECONDARY outcome
Timeframe: IP: From date of first dose up to end of period (approximately 1.4 years), CP: From date of first dose up to end of period (approximately 1.8 years), MP: From date of first dose up to the end of period (approximately 3.8 years)Population: The analysis population consisted of FAS participants, regardless of whether they proceeded to induction, consolidation or maintenance. CR rate after: induction included participants from start of treatment through induction; consolidation included participants from induction through consolidation and maintenance included participants from induction through maintenance.
Percentage of participants with CR/CRh was reported. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm\^3 and platelet count of ≥ 100,000/mm\^3, bone marrow blasts \< 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. CRh was defined as a condition at the post baseline visit, having bone marrow blasts \< 5%, partial hematologic recovery neutrophil count≥ 500/mm\^3 and platelet count ≥ 50,000/mm\^3, no evidence of extramedullary leukemia and could be classified as CR. The blast counts in peripheral blood was ≤ 2%. Derived response assessment after the IP refers to the best response from the start of treatment in the IP until the end of the IP, after CP refers to the best response from the start of treatment in the IP until the end of the CP and for the MP refers to the best response from the start of treatment in the IP until the end of the MP.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=82 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: CR/CRh Rate After Each Treatment Therapy Period
After Induction Period
|
67.1 Percentage of participants
Interval 55.8 to 77.1
|
—
|
|
Phase 2 Part: CR/CRh Rate After Each Treatment Therapy Period
After Consolidation Period
|
73.2 Percentage of participants
Interval 62.2 to 82.4
|
—
|
|
Phase 2 Part: CR/CRh Rate After Each Treatment Therapy Period
After Maintenance Period
|
73.2 Percentage of participants
Interval 62.2 to 82.4
|
—
|
SECONDARY outcome
Timeframe: From the date of achieving CR up to the date of documented relapse (maximum duration: approximately 2.6 years)Population: FAS with available data analyzed.
Duration of CR was defined as the time from the date of achieving first CR until the date of first documented relapse for participants who achieved CR. KM estimate was used for analysis. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm\^3 and platelet count of ≥ 100,000/mm\^3, bone marrow blasts \< 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. Relapse: reappearance of leukemic blasts in peripheral blood (\>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to \> 25%.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=55 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: Duration of CR
|
NA Months
The median survival time and the upper/lower limits of the confidence interval of median survival time were not estimable, since the KM plot and its upper/lower limit of the confidence interval did not reach 50% survival due to insufficient number of events.
|
—
|
SECONDARY outcome
Timeframe: From the date of achieving CR/CRh up to the date of documented relapse (maximum duration: approximately 2.6 years)Population: FAS with available data analyzed.
Duration of CR/CRh is defined as the time from the date of achieving first CR/CRh until the date of first documented relapse for participants who achieved CR/CRh. KM estimate was used for analysis. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm\^3 and platelet count of ≥ 100,000/mm\^3, bone marrow blasts \< 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%. CRh was defined as a condition at the post baseline visit, having bone marrow blasts \< 5%, partial hematologic recovery neutrophil count≥ 500/mm\^3 and platelet count ≥ 50,000/mm\^3, no evidence of extramedullary leukemia and could be classified as CR. The blast counts in peripheral blood was ≤ 2%. Relapse: reappearance of leukemic blasts in peripheral blood (\>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to \> 25%.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=63 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: Duration of CR/CRh
|
NA Months
The median survival time and the upper/lower limits of the confidence interval of median survival time were not estimable, since the KM plot and its upper/lower limit of the confidence interval did not reach 50% survival due to insufficient number of events.
|
—
|
SECONDARY outcome
Timeframe: From the date of achieving CRh up to the date of documented relapse (maximum duration: approximately 2.6 years)Population: FAS with available data analyzed.
Duration of CRh was defined as the time from date of achieving first CRh until date of first documented relapse for participants who achieved CRh. KM estimate was used for analysis. CRh was defined as a condition at the post baseline visit, having bone marrow blasts \< 5%, partial hematologic recovery neutrophil count≥ 500/mm\^3 and platelet count ≥ 50,000/mm\^3, no evidence of extramedullary leukemia and could be classified as CR. The blast counts in peripheral blood was ≤ 2%. Relapse: reappearance of leukemic blasts in peripheral blood (\>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to \> 25%.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=45 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: Duration of CRh
|
NA Months
The median survival time and the upper/lower limits of the confidence interval of median survival time were not estimable, since the KM plot and its upper/lower limit of the confidence interval did not reach 50% survival due to insufficient number of events.
|
—
|
SECONDARY outcome
Timeframe: From the date of achieving CRc up to the date of documented relapse (maximum duration: approximately 2.7 years)Population: FAS with available data analyzed.
Duration of CRc is defined as the time from the date of achieving first CRc until the date of first documented relapse for participants who achieved CRc. KM estimate was used for analysis. CRc: rate of all complete \& incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi). CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (\< 100,000/mm\^3). CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (\< 1,000/mm\^3). CR: morphologically leukemia-free state at post-baseline visit, having neutrophil count of ≥ 1,000/mm\^3 and platelet count of ≥ 100,000/mm\^3, bone marrow blasts \< 5%. No evidence of Auer rods \& extramedullary leukemia. Blast counts in peripheral blood was ≤ 2%. Relapse: reappearance of leukemic blasts in peripheral blood (\>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to \> 25%.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=75 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: Duration of CRc
|
NA Months
The median survival time and the upper/lower limits of the confidence interval of median survival time were not estimable, since the KM plot and its upper/lower limit of the confidence interval did not reach 50% survival due to insufficient number of events.
|
—
|
SECONDARY outcome
Timeframe: From the date of achieving CR, CRp, CRi/PR up to the date of documented relapse (maximum duration: approximately 2.7 years)Population: FAS with available data analyzed.
DoR: from first day of achieving CRc (CR+ CRp,+CRi)/partial remission (PR) to first day of relapse. KM estimate was used for analysis. CR: morphologically leukemia-free state at post-baseline visit, having neutrophil count of ≥ 1,000/mm\^3 \& platelet count of ≥ 100,000/mm\^3, bone marrow blasts \< 5%. No evidence of Auer rods \& extramedullary leukemia. Peripheral blood blast counts was ≤ 2%. CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (\< 100,000/mm\^3). CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (\< 1,000/mm\^3). PR: condition with regeneration of normal hematopoietic cells in bone marrow, no detectable blasts, ≥ 50% decrease of blasts in BMA \& total bone marrow blasts of 5-25%. No evidence of extramedullary leukemia. Relapse: reappearance of leukemic blasts in peripheral blood (\>2%)/≥ 5% blasts in BMA/reappearance of numbers of peripheral blasts and an increase in percentage of blasts in BMA to \> 25%
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=76 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: Duration of Response (DoR)
|
NA Months
The median survival time and the upper/lower limits of the confidence interval of median survival time were not estimable, since the KM plot and its upper/lower limit of the confidence interval did not reach 50% survival due to insufficient number of events.
|
—
|
SECONDARY outcome
Timeframe: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years)Population: SAF
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE for Phase 2 was defined as an AE observed after the date of first dose until 30 days after the last dose. TEAE included both serious and non-serious AEs.
Outcome measures
| Measure |
Phase 1: Dose Evaluation (DEv)
n=84 Participants
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
Induction period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period:
Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|
|
Phase 2 Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
84 Participants
|
—
|
Adverse Events
Phase 1: Dose Evaluation (DEv)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1: Dose Expansion (DEx)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase 2: FLT3-mutated AML
Serious events: 45 serious events
Other events: 84 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Phase 1: Dose Evaluation (DEv)
n=3 participants at risk
Induction period (IP):
Participants received 120 milligrams (mg) giltertinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 milligrams per square meters per day \[mg/m\^2/day\] on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via intravenous (IV) infusion; in the induction period in cycles (C) 1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period (CP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period (MP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
n=10 participants at risk
Induction period (IP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period (CP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period (MP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 2: FLT3-mutated AML
n=84 participants at risk
Induction period (IP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 8 until blood recovery in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period (CP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 until blood recovery in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period (MP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 7 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
3.6%
3/84 • Number of events 5 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
4.8%
4/84 • Number of events 4 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
2.4%
2/84 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
7.1%
6/84 • Number of events 10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Immune system disorders
Acute graft versus host disease
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Brain abscess
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Liver abscess
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Meningitis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.7%
9/84 • Number of events 12 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Root canal infection
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.7%
9/84 • Number of events 11 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
3.6%
3/84 • Number of events 4 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Splenic abscess
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
2.4%
2/84 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Liver function test abnormal
|
33.3%
1/3 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 4 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Blood and lymphatic system disorders
Acquired antithrombin III deficiency
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Eye disorders
Corneal perforation
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
General disorders
Mucosal disorder
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Immune system disorders
Chronic graft versus host disease
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
2.4%
2/84 • Number of events 5 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
2.4%
2/84 • Number of events 6 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Prostate infection
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
2.4%
2/84 • Number of events 3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
Other adverse events
| Measure |
Phase 1: Dose Evaluation (DEv)
n=3 participants at risk
Induction period (IP):
Participants received 120 milligrams (mg) giltertinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 milligrams per square meters per day \[mg/m\^2/day\] on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via intravenous (IV) infusion; in the induction period in cycles (C) 1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period (CP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period (MP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 1: Dose Expansion (DEx)
n=10 participants at risk
Induction period (IP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period (CP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period (MP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
Phase 2: FLT3-mutated AML
n=84 participants at risk
Induction period (IP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 8 until blood recovery in combination with chemotherapy (idarubicin: 12 mg/m\^2/day on days 1 to 3, cytarabine: 100 mg/m\^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert.
Consolidation period (CP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 until blood recovery in combination with chemotherapy (cytarabine: 1500 mg/m\^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3. Each cycle was allowed to be extended until blood recovery was observed. Duration of infusion was determined based on site clinical practice and the local package insert.
Maintenance period (MP):
Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).
|
|---|---|---|---|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
13.1%
11/84 • Number of events 15 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
8.3%
7/84 • Number of events 7 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
2.4%
2/84 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
8.3%
7/84 • Number of events 9 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Skin and subcutaneous tissue disorders
Purpura
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
20.0%
2/10 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
38.1%
32/84 • Number of events 52 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 9 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
11.9%
10/84 • Number of events 15 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
11.9%
10/84 • Number of events 16 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Vascular disorders
Vasculitis
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
7.1%
6/84 • Number of events 6 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 6 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
7.1%
6/84 • Number of events 7 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 5 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
7.1%
6/84 • Number of events 16 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
9.5%
8/84 • Number of events 9 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 6 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
9.5%
8/84 • Number of events 9 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 5 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
7.1%
6/84 • Number of events 7 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
7.1%
6/84 • Number of events 6 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 5 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
13.1%
11/84 • Number of events 15 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.7%
9/84 • Number of events 12 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.7%
9/84 • Number of events 9 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
19.0%
16/84 • Number of events 32 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
3/3 • Number of events 14 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
60.0%
6/10 • Number of events 26 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
26.2%
22/84 • Number of events 107 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
3/3 • Number of events 7 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
90.0%
9/10 • Number of events 17 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
63.1%
53/84 • Number of events 110 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Blood and lymphatic system disorders
Leukopenia
|
66.7%
2/3 • Number of events 23 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
20.0%
2/10 • Number of events 20 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
8.3%
7/84 • Number of events 62 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • Number of events 18 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
30.0%
3/10 • Number of events 19 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
11.9%
10/84 • Number of events 65 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
3/3 • Number of events 27 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
20.0%
2/10 • Number of events 29 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
15.5%
13/84 • Number of events 88 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Endocrine disorders
Thyroiditis chronic
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
13.1%
11/84 • Number of events 12 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
41.7%
35/84 • Number of events 50 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
50.0%
5/10 • Number of events 7 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
39.3%
33/84 • Number of events 53 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
7.1%
6/84 • Number of events 8 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
2.4%
2/84 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 5 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 4 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
32.1%
27/84 • Number of events 50 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
30.0%
3/10 • Number of events 4 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
29.8%
25/84 • Number of events 34 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
19.0%
16/84 • Number of events 32 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
General disorders
Infusion site rash
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
General disorders
Oedema
|
66.7%
2/3 • Number of events 4 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 5 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
7.1%
6/84 • Number of events 9 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 8 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 6 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
46.4%
39/84 • Number of events 66 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
33.3%
1/3 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
9.5%
8/84 • Number of events 10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Immune system disorders
Hypogammaglobulinaemia
|
33.3%
1/3 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
20.2%
17/84 • Number of events 18 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Bronchiolitis
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
30.0%
3/10 • Number of events 7 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
3.6%
3/84 • Number of events 3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Cytomegalovirus infection
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
4.8%
4/84 • Number of events 4 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Device related infection
|
33.3%
1/3 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 5 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
4.8%
4/84 • Number of events 6 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.7%
9/84 • Number of events 9 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 6 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Pneumonia
|
66.7%
2/3 • Number of events 3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
50.0%
5/10 • Number of events 6 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
16.7%
14/84 • Number of events 16 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
4.8%
4/84 • Number of events 4 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
20.0%
2/10 • Number of events 4 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
15.5%
13/84 • Number of events 19 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
7.1%
6/84 • Number of events 7 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
4.8%
4/84 • Number of events 4 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
20.0%
2/10 • Number of events 3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
44.0%
37/84 • Number of events 112 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
33.3%
28/84 • Number of events 81 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
7.1%
6/84 • Number of events 6 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
3.6%
3/84 • Number of events 4 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Body temperature increased
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
30.0%
3/10 • Number of events 6 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
3.6%
3/84 • Number of events 3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 13 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Liver function test abnormal
|
66.7%
2/3 • Number of events 10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
30.0%
3/10 • Number of events 13 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 33 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
50.0%
5/10 • Number of events 21 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
32.1%
27/84 • Number of events 104 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
60.0%
6/10 • Number of events 33 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
34.5%
29/84 • Number of events 226 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
70.0%
7/10 • Number of events 34 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
17.9%
15/84 • Number of events 84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
30.0%
3/10 • Number of events 3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.7%
9/84 • Number of events 14 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
2.4%
2/84 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
3.6%
3/84 • Number of events 3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
20.0%
2/10 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
7.1%
6/84 • Number of events 6 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
20.0%
2/10 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.7%
9/84 • Number of events 9 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
8.3%
7/84 • Number of events 7 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
34.5%
29/84 • Number of events 70 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
8.3%
7/84 • Number of events 8 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
14.3%
12/84 • Number of events 16 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/84 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
7.1%
6/84 • Number of events 10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
9.5%
8/84 • Number of events 8 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
1.2%
1/84 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
20.0%
2/10 • Number of events 3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
3.6%
3/84 • Number of events 3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
7.1%
6/84 • Number of events 19 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
8.3%
7/84 • Number of events 7 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
21.4%
18/84 • Number of events 23 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
0.00%
0/10 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
6.0%
5/84 • Number of events 9 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
2/3 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
90.0%
9/10 • Number of events 9 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
17.9%
15/84 • Number of events 15 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
3.6%
3/84 • Number of events 3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
66.7%
2/3 • Number of events 2 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
40.0%
4/10 • Number of events 7 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
13.1%
11/84 • Number of events 21 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
10.0%
1/10 • Number of events 1 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
13.1%
11/84 • Number of events 11 • Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years.
SAF
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER