Trial Outcomes & Findings for Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia (NCT NCT02113982)
NCT ID: NCT02113982
Last Updated: 2024-08-01
Results Overview
Maximum tolerated dose (MTD) in both patients with BPDCN and AML. MTD defined as the highest dose level where less than 2/3 or 2/6 patients experienced a DLT
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
138 participants
Primary outcome timeframe
21-day period after the first dose (cycle 1)
Results posted on
2024-08-01
Participant Flow
Participant flow data and safety data collected by disease, study stage, and dose only. Baseline characteristics data collected by disease and study stage only.
Participant milestones
| Measure |
Stage 1 - AML Indication: 7 µg/kg/Day Dosage
All AML study patients who received 7 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 1 - AML Indication: 9 µg/kg/Day Dosage
All AML study patients who received 9 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 1 - AML Indication: 12 µg/kg/Day Dosage
All AML study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 1 - AML Indication: 16 µg/kg/Day Dosage
All AML study patients who received 16 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 1 - BPDCN Indication: 7 µg/kg/Day Dosage
All BPDCN study patients who received 7 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 2 - AML Indication: 12 µg/kg/Day Dosage
All AML study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 2 - AML Indication: 16 µg/kg/Day Dosage
All AML study patients who received 16 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 3 - BPDCN Indication: 12 µg/kg/Day Dosage
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Dose Escalation
STARTED
|
3
|
3
|
2
|
6
|
3
|
3
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: Dose Escalation
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: Dose Escalation
NOT COMPLETED
|
3
|
3
|
2
|
6
|
3
|
3
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2: Cohort Expansion
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
34
|
1
|
13
|
10
|
0
|
0
|
0
|
|
Stage 2: Cohort Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2: Cohort Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
34
|
1
|
13
|
10
|
0
|
0
|
0
|
|
Stage 3: Efficacy Cohort
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
13
|
0
|
0
|
|
Stage 3: Efficacy Cohort
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 3: Efficacy Cohort
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
13
|
0
|
0
|
|
Stage 4: First-line and R/R BPDCN
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
37
|
7
|
|
Stage 4: First-line and R/R BPDCN
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 4: First-line and R/R BPDCN
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
37
|
7
|
Reasons for withdrawal
| Measure |
Stage 1 - AML Indication: 7 µg/kg/Day Dosage
All AML study patients who received 7 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 1 - AML Indication: 9 µg/kg/Day Dosage
All AML study patients who received 9 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 1 - AML Indication: 12 µg/kg/Day Dosage
All AML study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 1 - AML Indication: 16 µg/kg/Day Dosage
All AML study patients who received 16 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 1 - BPDCN Indication: 7 µg/kg/Day Dosage
All BPDCN study patients who received 7 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 2 - AML Indication: 12 µg/kg/Day Dosage
All AML study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 2 - AML Indication: 16 µg/kg/Day Dosage
All AML study patients who received 16 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 3 - BPDCN Indication: 12 µg/kg/Day Dosage
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Dose Escalation
Adverse Event
|
0
|
0
|
2
|
4
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: Dose Escalation
Progressive Disease
|
3
|
1
|
0
|
2
|
2
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: Dose Escalation
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: Dose Escalation
Transplant
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: Dose Escalation
Other Therapy
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1: Dose Escalation
Complicating Disease
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2: Cohort Expansion
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Stage 2: Cohort Expansion
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Stage 2: Cohort Expansion
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
19
|
0
|
5
|
7
|
0
|
0
|
0
|
|
Stage 2: Cohort Expansion
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Stage 2: Cohort Expansion
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2: Cohort Expansion
Transplant
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
2
|
0
|
0
|
0
|
|
Stage 2: Cohort Expansion
Patient Preference
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Stage 2: Cohort Expansion
Other Therapy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Stage 3: Efficacy Cohort
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Stage 3: Efficacy Cohort
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Stage 3: Efficacy Cohort
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
|
Stage 3: Efficacy Cohort
Transplant
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
|
Stage 4: First-line and R/R BPDCN
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
|
Stage 4: First-line and R/R BPDCN
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
2
|
|
Stage 4: First-line and R/R BPDCN
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
3
|
|
Stage 4: First-line and R/R BPDCN
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
2
|
|
Stage 4: First-line and R/R BPDCN
Transplant
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
|
Stage 4: First-line and R/R BPDCN
Radiation Consolidation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Stage 4: First-line and R/R BPDCN
Patient Preference
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
First-line BPDCN- Stage 1
n=6 Participants
Dose Escalation, 7 or 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
First-line BPDCN - Stage 2
n=13 Participants
Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
First-line BPDCN - Stage 3
n=13 Participants
Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
First-line BPDCN - Stage 4
n=36 Participants
Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R BPDCN - Stage 1
n=3 Participants
Dose Escalation, 12 µg/kg/ day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R BPDCN - Stage 2
n=10 Participants
Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R BPDCN - Stage 4
n=6 Participants
Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
AML - Stage 1
n=14 Participants
Dose Escalation 7, 9,12 or 16 µg/kg/ day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
AML - Stage 2
n=35 Participants
Administration of 12 µg/kg/ day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 10.49 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 17.72 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 17.15 • n=5 Participants
|
64.1 years
STANDARD_DEVIATION 14.71 • n=4 Participants
|
72 years
STANDARD_DEVIATION 7.94 • n=21 Participants
|
69.7 years
STANDARD_DEVIATION 9.31 • n=8 Participants
|
67.5 years
STANDARD_DEVIATION 15.32 • n=8 Participants
|
58.6 years
STANDARD_DEVIATION 11.17 • n=24 Participants
|
61.2 years
STANDARD_DEVIATION 16.01 • n=42 Participants
|
63.4 years
STANDARD_DEVIATION 14.64 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
100 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
31 Participants
n=42 Participants
|
120 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
|
ECOG Performance Status Scale
ECOG 0
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
51 Participants
n=42 Participants
|
|
ECOG Performance Status Scale
ECOG 1
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
26 Participants
n=42 Participants
|
78 Participants
n=42 Participants
|
|
ECOG Performance Status Scale
ECOG 2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
ECOG Performance Status Scale
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 21-day period after the first dose (cycle 1)Population: Patients with First-line Blastic Plasmacytoid Dendritic Cell Neoplasm, R/R Blastic Plasmacytoid Dendritic Cell Neoplasm and Acute Myeloid Leukemia participating to stage 1 (dose-escalation)
Maximum tolerated dose (MTD) in both patients with BPDCN and AML. MTD defined as the highest dose level where less than 2/3 or 2/6 patients experienced a DLT
Outcome measures
| Measure |
First-line BPDCN
n=6 Participants
First-line BPDCN participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day or 12 µg/kg/day in stage 1
|
R/R BPDCN
n=3 Participants
R/R BPDCN who received at least 1 dose of Tagraxofusp either at 12 µg/kg/day in Stage 1
|
Acute Myeloid Leukemia
n=14 Participants
AML participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day, 9 µg/kg/day, 12 µg/kg/day or 16 µg/kg/day in Stage 1
|
|---|---|---|---|
|
MTD (Stage 1)
|
12 µg/kg/day
|
12 µg/kg/day
|
16 µg/kg/day
|
PRIMARY outcome
Timeframe: at pre-defined treatment cycle intervals from randomization up to disease progression, up to 3.5 yearsPopulation: Pre-defined efficacy primary end point assessed in Stage 3, standalone, pivotal efficacy cohort of only patients with first-line BPDCN exposed to 12 μg/kg/day were enrolled.
Complete response (CR) rate, defined as the percentage who achieved CR+ CR(clinical) with minimal residual skin abnormality (CRc) after treatment with Tagraxofusp. CR criteria according to Cheson BD et al, The International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-586: Marrow: normalization of blast percentage (≤5%). Peripheral blood: normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) - absence of leukemic blasts Skin: 100% clearance of all skin lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: regression to normal size on CT Spleen, liver: not palpable, nodules disappeared CRc criteria: all the above except for skin: marked clearance of all skin lesions from baseline; residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed)
Outcome measures
| Measure |
First-line BPDCN
n=13 Participants
First-line BPDCN participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day or 12 µg/kg/day in stage 1
|
R/R BPDCN
R/R BPDCN who received at least 1 dose of Tagraxofusp either at 12 µg/kg/day in Stage 1
|
Acute Myeloid Leukemia
AML participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day, 9 µg/kg/day, 12 µg/kg/day or 16 µg/kg/day in Stage 1
|
|---|---|---|---|
|
CR Rate in First-line BPDCN (Stage 3, Pivotal Cohort)
|
53.8 percentage of participants
Interval 25.1 to 80.8
|
—
|
—
|
SECONDARY outcome
Timeframe: at pre-defined treatment cycle intervals from randomization up to disease progression, up to 5 yearsPopulation: Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML.
CR rate, defined as the percentage of patients who achieved CR+ CR with minimal residual skin abnormality (CRc) after treatment with Tagraxofusp. CR criteria according to Cheson BD et al, The International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-586: Marrow: normalization of blast percentage (≤5%) Peripheral blood: normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) - absence of leukemic blasts Skin: 100% clearance of all skin lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: regression to normal size on CT Spleen, liver: not palpable, nodules disappeared CRc criteria: all the above except for skin: marked clearance of all skin lesions from baseline; residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed)
Outcome measures
| Measure |
First-line BPDCN
n=65 Participants
First-line BPDCN participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day or 12 µg/kg/day in stage 1
|
R/R BPDCN
n=19 Participants
R/R BPDCN who received at least 1 dose of Tagraxofusp either at 12 µg/kg/day in Stage 1
|
Acute Myeloid Leukemia
n=36 Participants
AML participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day, 9 µg/kg/day, 12 µg/kg/day or 16 µg/kg/day in Stage 1
|
|---|---|---|---|
|
CR Rate in First-line BPDCN, R/R BPDCN and AML
|
56.9 percentage of evaluable patients
Interval 44.0 to 69.2
|
15.8 percentage of evaluable patients
Interval 3.4 to 39.6
|
3 percentage of evaluable patients
Interval 0.1 to 14.2
|
SECONDARY outcome
Timeframe: at pre-defined treatment cycle intervals from randomization up to disease progression, up to 5 yearsPopulation: Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML
Duration of complete response (CR) defined as the time from when the criteria are first met for CR+CRc (whichever was recorded first) until the date that the criteria for relapse after CR+CRc are met, according to the previously reported criteria for CR and CRc and following criteria of relapse after CR+CRc (Cheson BD et al. J Clin Oncol 2007;25:579-586.): Marrow: blast percentage \>5% (if no peripheral blasts, then confirmation aspirate required ≥ 1week later) Peripheral blood: presence of leukemic blasts Skin: increase in skin score greater than the sum of nadir plus 50% baseline score Nodal masses: appearance of a new lesion(s) \>1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase from nadir in longest diameter of a previously identified node \>1cm in short axis Spleen, liver: \>50% increase from nadir in the SPD of any previous lesions
Outcome measures
| Measure |
First-line BPDCN
n=65 Participants
First-line BPDCN participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day or 12 µg/kg/day in stage 1
|
R/R BPDCN
n=19 Participants
R/R BPDCN who received at least 1 dose of Tagraxofusp either at 12 µg/kg/day in Stage 1
|
Acute Myeloid Leukemia
n=36 Participants
AML participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day, 9 µg/kg/day, 12 µg/kg/day or 16 µg/kg/day in Stage 1
|
|---|---|---|---|
|
Duration of CR in First-line BPDCN, R/R BPDCN and AML
|
24.9 months
Interval 0.99 to 57.36
|
3.6 months
Interval 3.02 to 13.93
|
8.6 months
1 participant only experienced CR
|
SECONDARY outcome
Timeframe: at pre-defined treatment cycle intervals from randomization up to disease progression, up to 5 yearsPopulation: Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML
Objective response rate (ORR) defines as the percentage of patients who achieved CR (CR+CRc), CR with incomplete blood count recovery (CRi), or partial response (PR) after treatment with Tagraxofusp according to the previously reported definitions of CR, CRc and the following one of CRi and PR: CRi: CR with incomplete of neutrophil and/or platelet count and absence of leukemic blast in the peripheral blood Marrow: PR defined as decrease by ≥50% in blast percentage to 5-25% Peripheral blood: PR defined as normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) Skin: 50%-\<100% clearance of all skis lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes Spleen, liver: ≥50% in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen
Outcome measures
| Measure |
First-line BPDCN
n=65 Participants
First-line BPDCN participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day or 12 µg/kg/day in stage 1
|
R/R BPDCN
n=19 Participants
R/R BPDCN who received at least 1 dose of Tagraxofusp either at 12 µg/kg/day in Stage 1
|
Acute Myeloid Leukemia
n=36 Participants
AML participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day, 9 µg/kg/day, 12 µg/kg/day or 16 µg/kg/day in Stage 1
|
|---|---|---|---|
|
ORR in First-line BPDCN, R/R BPDCN and AML
|
75.4 percentage of evaluable patients
Interval 63.1 to 85.2
|
57.9 percentage of evaluable patients
Interval 33.5 to 79.7
|
3 percentage of evaluable patients
Interval 0.1 to 14.2
|
SECONDARY outcome
Timeframe: From first infusion to treatment discontinuation when survival is assessed every 90 days up to end of follow-up or death, up to 5 yearsPopulation: Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML
Overall survival (months) defined as the time from the date of first infusion of Tagraxofusp to the date of death from any cause
Outcome measures
| Measure |
First-line BPDCN
n=65 Participants
First-line BPDCN participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day or 12 µg/kg/day in stage 1
|
R/R BPDCN
n=19 Participants
R/R BPDCN who received at least 1 dose of Tagraxofusp either at 12 µg/kg/day in Stage 1
|
Acute Myeloid Leukemia
n=36 Participants
AML participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day, 9 µg/kg/day, 12 µg/kg/day or 16 µg/kg/day in Stage 1
|
|---|---|---|---|
|
OS in First-line BPDCN, R/R BPDCN and AML
|
15.8 Months
Interval 9.7 to 25.8
|
8.2 Months
Interval 4.1 to 11.9
|
5.7 Months
range 0.49-24 months. 95% CI not estimable
|
SECONDARY outcome
Timeframe: at pre-defined intervals up to achievement of outcome enabling an SCT for a period, up to 5 yearsPopulation: Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML
Bridge to Stem Cell Transplant (SCT) defined as the percentage of patients who received SCT subsequent to achieving an Investigator-determined outcome from Tagraxofusp that was deemed by the Investigator to enable an SCT
Outcome measures
| Measure |
First-line BPDCN
n=65 Participants
First-line BPDCN participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day or 12 µg/kg/day in stage 1
|
R/R BPDCN
n=19 Participants
R/R BPDCN who received at least 1 dose of Tagraxofusp either at 12 µg/kg/day in Stage 1
|
Acute Myeloid Leukemia
n=36 Participants
AML participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day, 9 µg/kg/day, 12 µg/kg/day or 16 µg/kg/day in Stage 1
|
|---|---|---|---|
|
Bridge to SCT in First-line BPDCN, R/R BPDCN and AML
|
32.3 percentage of evaluable patients
|
5.3 percentage of evaluable patients
|
3 percentage of evaluable patients
|
Adverse Events
Stage 1 - AML Indication: 7 µg/kg/Day Dosage
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1 - AML Indication: 9 µg/kg/Day Dosage
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1 - AML Indication: 12 µg/kg/Day Dosage
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Stage 1 - AML Indication: 16 µg/kg/Day Dosage
Serious events: 6 serious events
Other events: 6 other events
Deaths: 4 deaths
1L - Stage 1 - BPDCN Indication: 7 µg/kg/Day Dosage
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
1L - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
R/R - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Stage 2 - AML Indication: 12 µg/kg/Day Dosage
Serious events: 19 serious events
Other events: 34 other events
Deaths: 3 deaths
Stage 2 - AML Indication: 16 µg/kg/Day Dosage
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
1L - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
Serious events: 7 serious events
Other events: 13 other events
Deaths: 1 deaths
R/R - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
1L - Stage 3 - BPDCN Indication: 12 µg/kg/Day Dosage
Serious events: 4 serious events
Other events: 13 other events
Deaths: 1 deaths
1L - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage
Serious events: 20 serious events
Other events: 37 other events
Deaths: 3 deaths
R/R - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage
Serious events: 5 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Stage 1 - AML Indication: 7 µg/kg/Day Dosage
n=3 participants at risk
All AML study patients who received 7 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 1 - AML Indication: 9 µg/kg/Day Dosage
n=3 participants at risk
All AML study patients who received 9 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 1 - AML Indication: 12 µg/kg/Day Dosage
n=2 participants at risk
All AML study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 1 - AML Indication: 16 µg/kg/Day Dosage
n=6 participants at risk
All AML study patients who received 16 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 1 - BPDCN Indication: 7 µg/kg/Day Dosage
n=3 participants at risk
All BPDCN study patients who received 7 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
n=3 participants at risk
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
n=3 participants at risk
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 2 - AML Indication: 12 µg/kg/Day Dosage
n=34 participants at risk
All AML study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 2 - AML Indication: 16 µg/kg/Day Dosage
n=1 participants at risk
All AML study patients who received 16 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
n=13 participants at risk
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
n=10 participants at risk
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 3 - BPDCN Indication: 12 µg/kg/Day Dosage
n=13 participants at risk
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage
n=37 participants at risk
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage
n=7 participants at risk
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.6%
7/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Disease progression
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Fatigue
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Empyema
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
4/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
11.8%
4/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
13.5%
5/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
11.8%
4/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Hypothermia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Non Cardiac Chest Pain
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Facial Paralysis
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Pneumonia Respiratory Syncytial Viral
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Streptococcal Urinary Tract Infection
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Injury, poisoning and procedural complications
Allergic Transfusion Reaction
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
Other adverse events
| Measure |
Stage 1 - AML Indication: 7 µg/kg/Day Dosage
n=3 participants at risk
All AML study patients who received 7 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 1 - AML Indication: 9 µg/kg/Day Dosage
n=3 participants at risk
All AML study patients who received 9 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 1 - AML Indication: 12 µg/kg/Day Dosage
n=2 participants at risk
All AML study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 1 - AML Indication: 16 µg/kg/Day Dosage
n=6 participants at risk
All AML study patients who received 16 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 1 - BPDCN Indication: 7 µg/kg/Day Dosage
n=3 participants at risk
All BPDCN study patients who received 7 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
n=3 participants at risk
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
n=3 participants at risk
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 2 - AML Indication: 12 µg/kg/Day Dosage
n=34 participants at risk
All AML study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
Stage 2 - AML Indication: 16 µg/kg/Day Dosage
n=1 participants at risk
All AML study patients who received 16 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
n=13 participants at risk
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
n=10 participants at risk
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 3 - BPDCN Indication: 12 µg/kg/Day Dosage
n=13 participants at risk
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
1L - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage
n=37 participants at risk
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
R/R - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage
n=7 participants at risk
All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
4/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.5%
8/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
21.6%
8/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
38.2%
13/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
13.5%
5/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
11.8%
4/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.8%
3/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
11.8%
4/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
40.0%
4/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.2%
6/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
3/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.6%
7/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
53.8%
7/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
5/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
38.5%
5/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
32.4%
12/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
42.9%
3/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Cardiac disorders
Atrial fibrillation
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.2%
6/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Cardiac disorders
Cardiac failure congestive
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Cardiac disorders
Palpitations
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
11.8%
4/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
11.8%
4/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
18.9%
7/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.8%
3/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.6%
7/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
38.5%
5/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
27.0%
10/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
26.5%
9/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
38.5%
5/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
18.9%
7/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.8%
3/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
42.9%
3/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Gingival bleeding
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Lip pain
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
52.9%
18/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
61.5%
8/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
5/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
38.5%
5/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
35.1%
13/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Oral mucosa haematoma
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Retching
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.8%
3/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Tongue blistering
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
26.5%
9/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Asthenia
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Chest discomfort
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Chills
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
26.5%
9/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.8%
4/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
5/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.2%
6/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Disease progression
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Face oedema
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Facial pain
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Fatigue
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
2/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
3/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
44.1%
15/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
46.2%
6/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
5/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
53.8%
7/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
40.5%
15/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Malaise
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.7%
5/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Oedema peripheral
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
35.3%
12/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
46.2%
6/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
60.0%
6/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.8%
4/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
27.0%
10/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
71.4%
5/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Pain
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Pyrexia
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
2/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
4/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
35.3%
12/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
38.5%
5/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
60.0%
6/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
48.6%
18/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.8%
3/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
11.8%
4/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Empyema
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Incision site cellulitis
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
11.8%
4/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Tongue fungal infection
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.8%
3/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
3/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
58.8%
20/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
61.5%
8/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
5/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
76.9%
10/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
64.9%
24/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
42.9%
3/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
2/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
83.3%
5/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
64.7%
22/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
53.8%
7/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
5/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
69.2%
9/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
59.5%
22/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
42.9%
3/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
3/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.8%
3/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
11.8%
4/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.0%
3/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
3/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
11.8%
4/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Troponin I increased
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Investigations
Weight increased
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.6%
7/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
46.2%
6/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
46.2%
6/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
32.4%
12/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
2/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.5%
8/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.8%
4/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
4/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.6%
7/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.0%
3/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
38.5%
5/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
27.0%
10/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.8%
4/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.2%
6/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.8%
3/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
4/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
61.8%
21/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
80.0%
8/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
53.8%
7/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
45.9%
17/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
42.9%
3/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
2/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
42.9%
3/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.5%
8/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
38.5%
5/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
18.9%
7/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
11.8%
4/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
21.6%
8/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
11.8%
4/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.8%
3/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.7%
5/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.0%
3/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.8%
4/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
13.5%
5/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
11.8%
4/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Dizziness
|
100.0%
3/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.5%
8/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.2%
6/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
42.9%
3/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Hemorrhage intracranial
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
32.4%
11/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
38.5%
5/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.8%
4/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
24.3%
9/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Hyperaesthesia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Lethargy
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Syncope
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.2%
6/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.8%
3/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.6%
7/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.8%
3/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.7%
5/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hemorrhage
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
26.5%
9/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
29.4%
10/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.0%
3/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
18.9%
7/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
26.5%
9/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
11.8%
4/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.8%
3/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.8%
4/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
1/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.7%
5/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.7%
1/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
20.0%
2/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
16.7%
1/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.8%
4/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
2.9%
1/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
17.6%
6/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.0%
3/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
21.6%
8/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
28.6%
2/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
10.0%
1/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Vascular disorders
Flushing
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.9%
2/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
7.7%
1/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
5.4%
2/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
2/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.8%
3/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
15.4%
2/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.0%
3/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.8%
4/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
8.1%
3/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
33.3%
1/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
2/2 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
50.0%
3/6 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
0.00%
0/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
66.7%
2/3 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.5%
8/34 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
100.0%
1/1 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
23.1%
3/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
40.0%
4/10 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
30.8%
4/13 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
18.9%
7/37 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
14.3%
1/7 • From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place