Trial Outcomes & Findings for CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma (NCT NCT00659425)
NCT ID: NCT00659425
Last Updated: 2017-10-02
Results Overview
Adverse events that were suspected of a relationship to moxetumomab pasudotox and were greater than or equal to (\>=) Grade 3 in severity were considered DLTs with the following additional criteria or exceptions: Participants with hematologic abnormalities of any grade, Grade 2 allergic reactions of bronchospasm or urticaria, or any Grade ≥ 3 allergic reaction, in the presence of premedication.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
Day 1 up to 21 days of Cycle 1 (each cycle duration was of 21 days)
Results posted on
2017-10-02
Participant Flow
A total of 57 participants were enrolled of which 55 participants received treatment.
Participant milestones
| Measure |
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
4
|
4
|
5
|
8
|
11
|
6
|
14
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
4
|
4
|
4
|
8
|
11
|
6
|
13
|
Reasons for withdrawal
| Measure |
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Disease progression
|
1
|
0
|
0
|
1
|
0
|
2
|
4
|
3
|
5
|
3
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
1
|
4
|
|
Overall Study
Investigator Discretion
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
0
|
0
|
|
Overall Study
Other
|
0
|
1
|
1
|
2
|
4
|
0
|
3
|
2
|
0
|
6
|
Baseline Characteristics
CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
5 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=5 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=8 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=11 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=14 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
17 Years
STANDARD_DEVIATION NA • n=5 Participants
|
8 Years
STANDARD_DEVIATION NA • n=7 Participants
|
17 Years
STANDARD_DEVIATION NA • n=5 Participants
|
12.8 Years
STANDARD_DEVIATION 6.8 • n=4 Participants
|
9 Years
STANDARD_DEVIATION 2.7 • n=21 Participants
|
14 Years
STANDARD_DEVIATION 4.7 • n=10 Participants
|
8.6 Years
STANDARD_DEVIATION 5.3 • n=115 Participants
|
13.8 Years
STANDARD_DEVIATION 6.3 • n=24 Participants
|
12.8 Years
STANDARD_DEVIATION 8.3 • n=42 Participants
|
14.3 Years
STANDARD_DEVIATION 5.5 • n=42 Participants
|
12.7 Years
STANDARD_DEVIATION 5.9 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 21 days of Cycle 1 (each cycle duration was of 21 days)Population: Evaluable Population for DLT included all participants who received any treatment of moxetumomab pasudotox (CAT-8015) and completed the DLT period without a DLT, or did not complete the DLT period due to a DLT. Here, "N" is number of participants evaluated for this outcome measure.
Adverse events that were suspected of a relationship to moxetumomab pasudotox and were greater than or equal to (\>=) Grade 3 in severity were considered DLTs with the following additional criteria or exceptions: Participants with hematologic abnormalities of any grade, Grade 2 allergic reactions of bronchospasm or urticaria, or any Grade ≥ 3 allergic reaction, in the presence of premedication.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=3 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=3 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=7 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=7 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=3 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=11 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: From start of study drug administration until 30 days after the last dose of study drugPopulation: Safety Population included all participants who received any treatment of study drug.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=5 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=8 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=11 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=14 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TESAEs
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
11 Participants
|
6 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration until 30 days after the last dose of study drugPopulation: Safety Population included all participants who received any treatment of study drug.
Vital signs included parameters as heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=5 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=8 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=11 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=14 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Tachycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Arrhythmia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Bradycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Sinus bradycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypotension
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Sinus tachycardia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Pyrexia
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Dyspnoea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Respiratory distress
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Tachypnoea
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypertension
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 30 days after the last dose of study drugPopulation: Safety population included all participants who received any treatment of study drug.
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with grade 3 or higher treatment-emergent adverse events (5% cut off) for laboratory abnormalities were reported as clinically relevant laboratory changes.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=5 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=8 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=11 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=14 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Febrile neutropenia
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Anemia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Leukopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Lymphopenia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Neutropenia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Thrombocytopenia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 30 days after the last dose of study drugPopulation: Safety population included all participants who received any treatment of study drug.
An abnormal chemistry finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=5 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=8 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=11 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=14 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
Alanine aminotransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
Aspartate aminotransferase increased
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
Blood creatinine increased
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
|
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
Blood lactate dehydrogenase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
Blood urea increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
Hyperglycaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
Hyperphosphataemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
Hypoalbuminaemia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
Hypocalcaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
Hypokalaemia
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
Hypomagnesaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
Hyponatraemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
Hypophosphataemia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)Population: Safety population included all participants who received any treatment of study drug.
Ophthalmologic examination included evaluation of retinal, corneal and lens abnormalities at baseline and end of treatment that were not present at screening. Participants who experienced abnormalitities during ophthalmologic examination recorded and reported.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=5 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=8 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=11 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=14 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormalities in Ophthalmologic Examination at End of Treatment That Were Not Present at Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)Population: Safety population included all participants who received any treatment of study drug.
Number of participants with abnormal ECG changes (compared with baseline) as assessed by study cardiologist
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=7 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=7 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=12 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Normal Sinus Rhythm Findings in ECG
|
0 participants
Interval 0.2 to 0.2
|
0 participants
Interval 3.6 to 3.6
|
0 participants
Interval 1.7 to 1.7
|
0 participants
Interval 0.6 to 31.3
|
0 participants
Interval 0.7 to 1.4
|
0 participants
Interval 1.6 to 9.0
|
0 participants
Interval 1.8 to 42.0
|
0 participants
Interval 1.7 to 13.7
|
0 participants
Interval 0.9 to 7.9
|
0 participants
Interval 1.9 to 26.1
|
PRIMARY outcome
Timeframe: Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)Population: Safety population included all participants who received any treatment of study drug.
The 12-lead ECG data were summarized and evaluated for the following parameters: ,QT, QTC intervals and ventricular rate. Change from baseline in these parameters were reported.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=5 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=8 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=11 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=14 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in Clinical Findings in Electrocardiogram (ECG) QT, QTC Interval and Ventricular Rate
QT interval
|
-107 milli seconds (msec)
Standard Deviation NA
Only 1 subject analyzed at baseline and end of treatment so SD is not applicable
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
-52.0 milli seconds (msec)
Standard Deviation NA
Of the 4 subjects with data, only 1 subject had analyzable data at baseline and end of treatment so SD is not applicable
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
|
Change From Baseline to End of Treatment in Clinical Findings in Electrocardiogram (ECG) QT, QTC Interval and Ventricular Rate
QTC interval
|
20.0 milli seconds (msec)
Standard Deviation NA
Only 1 subject analyzed at baseline and end of treatment so SD is not applicable
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
-26.0 milli seconds (msec)
Standard Deviation NA
Of the 4 subjects with data, only 1 subject had analyzable data at baseline and end of treatment so SD is not applicable
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
|
Change From Baseline to End of Treatment in Clinical Findings in Electrocardiogram (ECG) QT, QTC Interval and Ventricular Rate
Ventricluar rate
|
69.0 milli seconds (msec)
Standard Deviation NA
Only 1 subject analyzed at baseline and end of treatment so SD is not applicable
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
29.0 milli seconds (msec)
Standard Deviation NA
Of the 4 subjects with data, only 1 subject had analyzable data at baseline and end of treatment so SD is not applicable
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
NA milli seconds (msec)
Standard Deviation NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
|
PRIMARY outcome
Timeframe: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)Population: Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, "N" is number of participants analyzed for this outcome measure.
Antitumor activity was assessed by best overall tumor response.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=7 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=7 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=12 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Tumor Response
Composite complete response
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Best Overall Tumor Response
Complete response
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Best Overall Tumor Response
Progressive disease
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Best Overall Tumor Response
complete response with incomplete count recovery
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Tumor Response
Partial response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Best Overall Tumor Response
Hematological activity
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Best Overall Tumor Response
Stable disease
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)Population: Efficacy population included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug. Here, "N" is number of participants analyzed for this outcome measure.
Objective response based on assessment of confirmed composite complete response (CRc) or partial response (PR) according to disease specific criteria \[modified criteria for response in acute lymphoblastic leukemia (ALL)\].
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=7 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=7 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=12 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 percentage of participants
|
100 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
14.3 percentage of participants
|
42.9 percentage of participants
|
33.3 percentage of participants
|
41.7 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)Population: Efficacy population. Here, "N" is number of participants with CR in the respective cohort. Rate of relapse could not be estimated as none of the participants experienced CR in the 5 mcg/kg, 20 mcg/kg (Schema A) and 30 mcg/kg (schema A) cohort of the study.
Relapse is defined as progressive disease (PD) following complete response (CR). Rate of relapse was only calculated for the subgroup of participants with complete response.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=1 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=2 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=3 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Relapse of Disease
|
—
|
0 percentage of participants
|
—
|
100 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
50 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)Population: Evaluable Population for Efficacy. Here, "N" is number of participants with objective disease response in the respective cohort. Time to disease response could not be estimated as none of the participants experienced OR in the 5 mcg/kg, 20 mcg/kg (schema A) and 30 mcg/kg (schema A).
Time to disease response was measured from the start of moxetumomab pasudotox administration to the first documentation of response (CR or PR) and was assessed in participants who achieved objective response.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=2 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=1 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=3 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=2 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=5 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Disease Response
|
—
|
0.69 months
Interval 0.69 to 0.69
|
—
|
0.49 months
Interval 0.49 to 0.49
|
—
|
0.66 months
Interval 0.59 to 0.72
|
0.49 months
Interval 0.49 to 0.49
|
0.72 months
Interval 0.72 to 0.76
|
0.62 months
Interval 0.59 to 0.66
|
0.66 months
Interval 0.59 to 0.72
|
PRIMARY outcome
Timeframe: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatmentPopulation: Evaluable Population for Efficacy. Here, "N" is number of participants with objective disease response in the respective cohort. DR could not be estimated as none of the participants experienced OR in the 5 mcg/kg, 20 mcg/kg (schema A) and 30 mcg/kg (schema A).
Duration of response was defined as the duration from the first documentation of objective response to the first documented disease progression.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=2 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=1 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=3 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=2 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=5 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DR)
|
—
|
NA months
Interval 1.9 to 1.9
Median DR was estimated using the Kaplan-Meier survival analysis. Where median DR = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
|
—
|
2.3 months
Interval 2.3 to 2.3
|
—
|
NA months
Interval 0.7 to 1.4
Median DR was estimated using the Kaplan-Meier survival analysis. Where median DR = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
|
NA months
Interval 0.8 to 0.8
Median DR was estimated using the Kaplan-Meier survival analysis. Where median DR = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
|
NA months
Interval 0.0 to 0.9
Median DR was estimated using the Kaplan-Meier survival analysis. Where median DR = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
|
NA months
Interval 0.4 to 1.4
Median DR was estimated using the Kaplan-Meier survival analysis. Where median DR = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
|
NA months
Interval 0.0 to 2.0
Median DR was estimated using the Kaplan-Meier survival analysis. Where median DR = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
|
PRIMARY outcome
Timeframe: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatmentPopulation: Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, "N" is number of participants analyzed for this outcome measure.
Time to disease progression was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression. Number of progressions were reported here.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=7 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=7 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=12 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Disease Progression (TDP)
|
0.2 months
Interval 0.2 to 0.2
|
NA months
Interval 2.6 to 2.6
Median TDP was estimated using the Kaplan-Meier survival analysis. Where median TDP = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
|
NA months
Interval 0.6 to 0.6
Median TDP was estimated using the Kaplan-Meier survival analysis. Where median TDP = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
|
2 months
Interval 0.5 to 2.8
|
NA months
Interval 0.2 to 1.4
Median TDP was estimated using the Kaplan-Meier survival analysis. Where median TDP = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
|
NA months
Interval 0.5 to 2.2
Median TDP was estimated using the Kaplan-Meier survival analysis. Where median TDP = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
|
1.2 months
Interval 0.5 to 1.2
|
1.5 months
Interval 0.5 to 1.6
|
0.8 months
Interval 0.4 to 2.0
|
NA months
Interval 0.5 to 2.7
Median TDP was estimated using the Kaplan-Meier survival analysis. Where median TDP = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
|
PRIMARY outcome
Timeframe: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)Population: Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, "N" is number of participants analyzed for this outcome measure.
Progression-free survival was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression or death due to any cause, whichever occurs first. Number of progressions/deaths were reported here.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=7 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=7 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=12 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
0.2 months
Interval 0.2 to 0.2
|
3.6 months
Interval 3.6 to 3.6
|
1.7 months
Interval 1.7 to 1.7
|
1.8 months
Interval 0.6 to 2.8
|
NA months
Interval 0.2 to 1.4
Median PFS was estimated using the Kaplan-Meier survival analysis. Where median PFS = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
|
3.1 months
Interval 0.5 to 9.0
|
1.2 months
Interval 0.6 to 14.0
|
1.5 months
Interval 0.5 to 5.6
|
0.8 months
Interval 0.4 to 5.9
|
5.8 months
Interval 0.5 to 17.3
|
PRIMARY outcome
Timeframe: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)Population: Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, "N" is number of participants analyzed for this outcome measure.
Overall survival was determined as the time from the start of treatment with Moxetumomab Pasudotox until death. Number of deaths were reported here.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=7 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=7 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=12 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
0.2 months
Interval 0.2 to 0.2
|
3.6 months
Interval 3.6 to 3.6
|
1.7 months
Interval 1.7 to 1.7
|
2.1 months
Interval 0.6 to 31.3
|
NA months
Interval 0.7 to 1.4
Median OS was estimated using the Kaplan-Meier survival analysis. Where median OS = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
|
4.6 months
Interval 1.6 to 9.0
|
9.4 months
Interval 1.8 to 42.0
|
NA months
Interval 1.7 to 13.7
Median OS was estimated using the Kaplan-Meier survival analysis. Where median OS = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
|
4.1 months
Interval 0.9 to 7.9
|
12.7 months
Interval 1.9 to 26.1
|
PRIMARY outcome
Timeframe: Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6Population: Evaluable Population for efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.
The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=5 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=9 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=10 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=6 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=20 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Cmax below lower limit of quantification
|
126 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
274 nanogram per milliliter (ng/mL)
Standard Deviation 135
|
446 nanogram per milliliter (ng/mL)
Standard Deviation 126
|
446 nanogram per milliliter (ng/mL)
Standard Deviation 156
|
555 nanogram per milliliter (ng/mL)
Standard Deviation 196
|
755 nanogram per milliliter (ng/mL)
Standard Deviation 188
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6Population: Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.
The AUC (0 to infinity) is the area under the plasma concentration-time curve from time zero to infinity hours.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=3 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=8 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=10 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=5 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=20 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUC [0 to Infinity]) for Moxetumomab Pasudotox
|
NA hour*nanogram per milliliter (h.ng/mL)
Standard Deviation NA
AUC cannot be estimated due to insufficient samples from subject to be able to calculate AUC
|
NA hour*nanogram per milliliter (h.ng/mL)
Standard Deviation NA
AUC cannot be estimated due to insufficient samples from subject to be able to calculate AUC
|
744 hour*nanogram per milliliter (h.ng/mL)
Standard Deviation 514
|
1060 hour*nanogram per milliliter (h.ng/mL)
Standard Deviation 508
|
844 hour*nanogram per milliliter (h.ng/mL)
Standard Deviation 385
|
1320 hour*nanogram per milliliter (h.ng/mL)
Standard Deviation 554
|
1690 hour*nanogram per milliliter (h.ng/mL)
Standard Deviation 689
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6Population: Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.
The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma area under the plasma concentration-time curve from time zone to infinite time (AUC\[0-infinity\]).
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=3 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=8 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=10 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=5 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=20 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Systemic Clearance (CL) for Moxetumomab Pasudotox
|
NA milliliter per hour per kilogram
Standard Deviation NA
CL below lower limit of quantification
|
NA milliliter per hour per kilogram
Standard Deviation NA
CL below lower limit of quantification
|
40.5 milliliter per hour per kilogram
Standard Deviation 32.3
|
35.4 milliliter per hour per kilogram
Standard Deviation 18.2
|
47.5 milliliter per hour per kilogram
Standard Deviation 28.2
|
34.6 milliliter per hour per kilogram
Standard Deviation 13.2
|
35.3 milliliter per hour per kilogram
Standard Deviation 14.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6Population: Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=3 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=8 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=10 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=5 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=20 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Phase Elimination Half Life (t1/2) for Moxetumomab Pasudotox
|
NA hour (h)
Standard Deviation NA
plasma concentration of moxetumomab pasudotox below the lower limit of quantification therefore t1/2 cannot be estimated
|
NA hour (h)
Standard Deviation NA
plasma concentration of moxetumomab pasudotox below the lower limit of quantification therefore t1/2 cannot be estimated
|
0.906 hour (h)
Standard Deviation 0.545
|
1.32 hour (h)
Standard Deviation 0.893
|
0.997 hour (h)
Standard Deviation 0.557
|
0.880 hour (h)
Standard Deviation 0.522
|
1.38 hour (h)
Standard Deviation 0.753
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)Population: Safety population included all participants who received any treatment of study drug.
Participants tested for immunogenicity to CAT-8015 (moxetumomab pasudotox) prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (\>)50 percentage (%) of the binding of CAT-8015 to CD22 using an ELISA-based method.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=5 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=8 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=11 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=14 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody
ADA present by screening assay
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody
Neutralizing ADA present by functional assay
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)Population: Safety population included all participants who received any treatment of study drug. Here, n = participants evaluable for specified category for each arm, respectively
Participants malignant cells (peripheral blood) was tested for cluster of differentiation 22 (CD22) expression by fluorescence-activated cell sorter (FACS) analysis.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=5 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=8 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=11 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=14 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
CD22 Expression Cells in Peripheral Blood by Best Response
Partial response (n=0,0,0,0,0,1,0,1,0,2)
|
NA sites per cell
No participants were evaluated.
|
NA sites per cell
No participants were evaluated.
|
NA sites per cell
No participants were evaluated.
|
NA sites per cell
No participants were evaluated.
|
NA sites per cell
No participants were evaluated.
|
2387.0 sites per cell
Interval 2387.0 to 2387.0
|
NA sites per cell
No participants were evaluated.
|
4514.0 sites per cell
Interval 4514.0 to 4514.0
|
NA sites per cell
No participants were evaluated.
|
2366.0 sites per cell
Interval 2312.0 to 2420.0
|
|
CD22 Expression Cells in Peripheral Blood by Best Response
Stable response (n=0,0,1,1,1,1,2,1,0,4)
|
NA sites per cell
No participants were evaluated.
|
NA sites per cell
No participants were evaluated.
|
5050.0 sites per cell
Interval 5050.0 to 5050.0
|
8083.0 sites per cell
Interval 8083.0 to 8083.0
|
2111.0 sites per cell
Interval 2111.0 to 2111.0
|
5587.0 sites per cell
Interval 5587.0 to 5587.0
|
8513.0 sites per cell
Interval 3045.0 to 13981.0
|
2521.0 sites per cell
Interval 2521.0 to 2521.0
|
NA sites per cell
No participants were evaluated.
|
3904.0 sites per cell
Interval 1226.0 to 11435.0
|
|
CD22 Expression Cells in Peripheral Blood by Best Response
Composite complete response(n=0,1,0,1,0,1,0,2,2,3)
|
NA sites per cell
No participants were evaluated.
|
14519.0 sites per cell
Interval 14519.0 to 14519.0
|
NA sites per cell
No participants were evaluated.
|
749.0 sites per cell
Interval 749.0 to 749.0
|
NA sites per cell
No participants were evaluated.
|
3058.0 sites per cell
Interval 3058.0 to 3058.0
|
NA sites per cell
No participants were evaluated.
|
2772.5 sites per cell
Interval 1650.0 to 3895.0
|
5620.0 sites per cell
Interval 3968.0 to 7272.0
|
4331.0 sites per cell
Interval 3085.0 to 10393.0
|
|
CD22 Expression Cells in Peripheral Blood by Best Response
Complete response (n=0,1,0,1,0,1,0,2,2,3)
|
NA sites per cell
No participants were evaluated.
|
14519.0 sites per cell
Interval 14519.0 to 14519.0
|
NA sites per cell
No participants were evaluated.
|
749.0 sites per cell
Interval 749.0 to 749.0
|
NA sites per cell
No participants were evaluated.
|
3058.0 sites per cell
Interval 3058.0 to 3058.0
|
NA sites per cell
No participants were evaluated.
|
2772.5 sites per cell
Interval 1650.0 to 3895.0
|
5620.0 sites per cell
Interval 3968.0 to 7272.0
|
4331.0 sites per cell
Interval 3085.0 to 10393.0
|
|
CD22 Expression Cells in Peripheral Blood by Best Response
Hematological activity (n=0,0,0,2,3,0,3,1,1,2)
|
NA sites per cell
No participants were evaluated.
|
NA sites per cell
No participants were evaluated.
|
NA sites per cell
No participants were evaluated.
|
3533.5 sites per cell
Interval 2214.0 to 4853.0
|
2476.0 sites per cell
Interval 1851.0 to 4821.0
|
NA sites per cell
No participants were evaluated.
|
1427.0 sites per cell
Interval 1194.0 to 4391.0
|
1350.0 sites per cell
Interval 1350.0 to 1350.0
|
2642.0 sites per cell
Interval 2642.0 to 2642.0
|
2223.5 sites per cell
Interval 1616.0 to 2831.0
|
|
CD22 Expression Cells in Peripheral Blood by Best Response
Progressive disease (n=1,0,0,0,0,1,1,2,3,1)
|
13210.0 sites per cell
Interval 13210.0 to 13210.0
|
NA sites per cell
No participants were evaluated.
|
NA sites per cell
No participants were evaluated.
|
NA sites per cell
No participants were evaluated.
|
NA sites per cell
No participants were evaluated.
|
3705.0 sites per cell
Interval 3705.0 to 3705.0
|
1415.0 sites per cell
Interval 1415.0 to 1415.0
|
5505.5 sites per cell
Interval 1354.0 to 9657.0
|
1643.0 sites per cell
Interval 1387.0 to 5359.0
|
3102.0 sites per cell
Interval 3102.0 to 3102.0
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)Population: Safety population included all participants who received any treatment of study drug.
Potential biomarkers include orthostatic blood pressure, albumin levels, weight change, edema and hypoxia were evaluated.
Outcome measures
| Measure |
10 Microgram Per Kilogram (mcg/kg)
n=1 Participants
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema A
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 Microgram Per Kilogram (mcg/kg): Schema B
n=1 Participants
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema A
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 Microgram Per Kilogram (mcg/kg): Schema B
n=4 Participants
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 Microgram Per Kilogram (mcg/kg): Schema B
n=5 Participants
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 Microgram Per Kilogram (mcg/kg): Schema C
n=8 Participants
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema B
n=11 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=6 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 Microgram Per Kilogram (mcg/kg): Schema C
n=14 Participants
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Hypertension; Event; Developed no later than CLS
|
0 participants
|
0 participants
Interval 14519.0 to 14519.0
|
0 participants
|
0 participants
Interval 749.0 to 749.0
|
0 participants
|
0 participants
Interval 3058.0 to 3058.0
|
0 participants
|
0 participants
Interval 1650.0 to 3895.0
|
0 participants
Interval 3968.0 to 7272.0
|
0 participants
Interval 3085.0 to 10393.0
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Hypertension; Event; Developed after CLS
|
0 participants
|
0 participants
Interval 14519.0 to 14519.0
|
0 participants
|
0 participants
Interval 749.0 to 749.0
|
2 participants
|
0 participants
Interval 3058.0 to 3058.0
|
0 participants
|
0 participants
Interval 1650.0 to 3895.0
|
0 participants
Interval 3968.0 to 7272.0
|
0 participants
Interval 3085.0 to 10393.0
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Hypertension; Event; No CLS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
Interval 2387.0 to 2387.0
|
0 participants
|
2 participants
Interval 4514.0 to 4514.0
|
1 participants
|
5 participants
Interval 2312.0 to 2420.0
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Hypertension; No Event; No CLS
|
1 participants
|
1 participants
|
1 participants
|
4 participants
Interval 2214.0 to 4853.0
|
2 participants
Interval 1851.0 to 4821.0
|
4 participants
|
8 participants
Interval 1194.0 to 4391.0
|
9 participants
Interval 1350.0 to 1350.0
|
5 participants
Interval 2642.0 to 2642.0
|
8 participants
Interval 1616.0 to 2831.0
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Weight change; Event; Developed no later than CLS
|
0 participants
Interval 13210.0 to 13210.0
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
Interval 3705.0 to 3705.0
|
0 participants
Interval 1415.0 to 1415.0
|
0 participants
Interval 1354.0 to 9657.0
|
0 participants
Interval 1387.0 to 5359.0
|
0 participants
Interval 3102.0 to 3102.0
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Weight change; Event; Developed after CLS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Weight change; Event; No CLS
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Weight change; No Event; No CLS
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
2 participants
|
3 participants
|
8 participants
|
8 participants
|
6 participants
|
10 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Weight change; No Event; CLS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Change in Albumin; Event; Developed no later CLS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Change in Albumin; Event; Developed after CLS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Change in Albumin; Event; No CLS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Change in Albumin; No Event; No CLS
|
1 participants
|
1 participants
|
1 participants
|
4 participants
|
2 participants
|
3 participants
|
8 participants
|
11 participants
|
6 participants
|
13 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Change in Albumin; No Event; CLS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Edema; Event; Developed no later than CLS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Edema; Event; Developed after CLS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Edema; Event; No CLS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Edema; No Event; CLS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Hypoxia; Event; Developed no later than CLS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Hypoxia; Event; Developed after CLS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Hypoxia; Event; No CLS
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Hypoxia; No Event; No CLS
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
2 participants
|
4 participants
|
7 participants
|
9 participants
|
4 participants
|
12 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Hypoxia; No Event; CLS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Hypertension; No Event; CLS
|
0 participants
|
0 participants
|
0 participants
Interval 5050.0 to 5050.0
|
0 participants
Interval 8083.0 to 8083.0
|
0 participants
Interval 2111.0 to 2111.0
|
1 participants
Interval 5587.0 to 5587.0
|
0 participants
Interval 3045.0 to 13981.0
|
0 participants
Interval 2521.0 to 2521.0
|
0 participants
|
1 participants
Interval 1226.0 to 11435.0
|
|
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Edema; No Event; No CLS
|
1 participants
|
1 participants
|
1 participants
|
4 participants
|
2 participants
|
4 participants
|
8 participants
|
11 participants
|
6 participants
|
13 participants
|
Adverse Events
5 UG/KG SCHEMA A
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
10 UG/KG SCHEMA A
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
20 UG/KG SCHEMA A
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
20 UG/KG SCHEMA B
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
30 UG/KG SCHEMA A
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
30 UG/KG SCHEMA B
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
40 UG/KG SCHEMA B
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
32 UG/KG SCHEMA C
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
50 UG/KG SCHEMA B
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
50 UG/KG SCHEMA C
Serious events: 9 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 UG/KG SCHEMA A
n=1 participants at risk
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
10 UG/KG SCHEMA A
n=1 participants at risk
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 UG/KG SCHEMA A
n=1 participants at risk
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 UG/KG SCHEMA B
n=4 participants at risk
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 UG/KG SCHEMA A
n=4 participants at risk
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 UG/KG SCHEMA B
n=5 participants at risk
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 UG/KG SCHEMA B
n=8 participants at risk
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 UG/KG SCHEMA C
n=11 participants at risk
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 UG/KG SCHEMA B
n=6 participants at risk
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 UG/KG SCHEMA C
n=14 participants at risk
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Central nervous system haemorrhage
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
21.4%
3/14 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Eye disorders
Choroidal detachment
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
General disorders
Brain death
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
General disorders
Multi-organ failure
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
General disorders
Pyrexia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Infections and infestations
Geotrichum infection
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
Blood creatinine increased
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Nervous system disorders
Coma
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
Proteinuria
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
2/4 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
General disorders
Disease progression
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Infections and infestations
Septic shock
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Infections and infestations
Systemic mycosis
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Infections and infestations
Tooth infection
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
Troponin
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
Renal failure
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
2/4 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Vascular disorders
Thrombosis
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Vascular disorders
Venoocclusive disease
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
Other adverse events
| Measure |
5 UG/KG SCHEMA A
n=1 participants at risk
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
10 UG/KG SCHEMA A
n=1 participants at risk
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 UG/KG SCHEMA A
n=1 participants at risk
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
20 UG/KG SCHEMA B
n=4 participants at risk
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 UG/KG SCHEMA A
n=4 participants at risk
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
30 UG/KG SCHEMA B
n=5 participants at risk
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
40 UG/KG SCHEMA B
n=8 participants at risk
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
32 UG/KG SCHEMA C
n=11 participants at risk
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
50 UG/KG SCHEMA B
n=6 participants at risk
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
|
50 UG/KG SCHEMA C
n=14 participants at risk
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 19 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 12 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 12 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
21.4%
3/14 • Number of events 17 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
2/4 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
36.4%
4/11 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
37.5%
3/8 • Number of events 7 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 12 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 13 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
37.5%
3/8 • Number of events 7 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 10 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 7 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 7 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 38 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 12 • From start of study drug administration up to 30 days after the last dose of study drug
|
37.5%
3/8 • Number of events 24 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 15 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Cardiac disorders
Sinus tachycardia
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
2/4 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
75.0%
3/4 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
60.0%
3/5 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
18.2%
2/11 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
21.4%
3/14 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
27.3%
3/11 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
21.4%
3/14 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
60.0%
3/5 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
21.4%
3/14 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
37.5%
3/8 • Number of events 5 • From start of study drug administration up to 30 days after the last dose of study drug
|
36.4%
4/11 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
2/4 • Number of events 7 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
4/8 • Number of events 7 • From start of study drug administration up to 30 days after the last dose of study drug
|
18.2%
2/11 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
35.7%
5/14 • Number of events 6 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 5 • From start of study drug administration up to 30 days after the last dose of study drug
|
18.2%
2/11 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
21.4%
3/14 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
General disorders
Catheter site pain
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
27.3%
3/11 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
General disorders
Fatigue
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
60.0%
3/5 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
36.4%
4/11 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
35.7%
5/14 • Number of events 5 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
2/4 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
80.0%
4/5 • Number of events 8 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 10 • From start of study drug administration up to 30 days after the last dose of study drug
|
18.2%
2/11 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
33.3%
2/6 • Number of events 6 • From start of study drug administration up to 30 days after the last dose of study drug
|
21.4%
3/14 • Number of events 8 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
60.0%
3/5 • Number of events 5 • From start of study drug administration up to 30 days after the last dose of study drug
|
62.5%
5/8 • Number of events 10 • From start of study drug administration up to 30 days after the last dose of study drug
|
18.2%
2/11 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
66.7%
4/6 • Number of events 7 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 5 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
3/6 • Number of events 5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
Blood urea increased
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
33.3%
2/6 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
75.0%
3/4 • Number of events 20 • From start of study drug administration up to 30 days after the last dose of study drug
|
40.0%
2/5 • Number of events 11 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
27.3%
3/11 • Number of events 5 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
57.1%
8/14 • Number of events 17 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
4/4 • Number of events 23 • From start of study drug administration up to 30 days after the last dose of study drug
|
80.0%
4/5 • Number of events 33 • From start of study drug administration up to 30 days after the last dose of study drug
|
37.5%
3/8 • Number of events 25 • From start of study drug administration up to 30 days after the last dose of study drug
|
54.5%
6/11 • Number of events 39 • From start of study drug administration up to 30 days after the last dose of study drug
|
66.7%
4/6 • Number of events 17 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
7/14 • Number of events 37 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
Weight increased
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
4/4 • Number of events 8 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
2/4 • Number of events 6 • From start of study drug administration up to 30 days after the last dose of study drug
|
40.0%
2/5 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
63.6%
7/11 • Number of events 15 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
3/6 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
28.6%
4/14 • Number of events 15 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
75.0%
3/4 • Number of events 16 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
2/4 • Number of events 10 • From start of study drug administration up to 30 days after the last dose of study drug
|
60.0%
3/5 • Number of events 5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 8 • From start of study drug administration up to 30 days after the last dose of study drug
|
36.4%
4/11 • Number of events 8 • From start of study drug administration up to 30 days after the last dose of study drug
|
33.3%
2/6 • Number of events 11 • From start of study drug administration up to 30 days after the last dose of study drug
|
57.1%
8/14 • Number of events 43 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
37.5%
3/8 • Number of events 5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 13 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
75.0%
3/4 • Number of events 7 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
18.2%
2/11 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 6 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
40.0%
2/5 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
4/8 • Number of events 5 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
37.5%
3/8 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
27.3%
3/11 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
21.4%
3/14 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
27.3%
3/11 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
18.2%
2/11 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
40.0%
2/5 • Number of events 5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
36.4%
4/11 • Number of events 6 • From start of study drug administration up to 30 days after the last dose of study drug
|
33.3%
2/6 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
7/14 • Number of events 10 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
2/4 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
28.6%
4/14 • Number of events 7 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
General disorders
Oedema
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
40.0%
2/5 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
18.2%
2/11 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
28.6%
4/14 • Number of events 7 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
36.4%
4/11 • Number of events 5 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
28.6%
4/14 • Number of events 6 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
General disorders
Pyrexia
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
75.0%
3/4 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
40.0%
2/5 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
18.2%
2/11 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
33.3%
2/6 • Number of events 5 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
7/14 • Number of events 15 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 6 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
Blood creatinine increased
|
100.0%
1/1 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
2/4 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
42.9%
6/14 • Number of events 13 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Investigations
Haemoglobin decreased
|
100.0%
1/1 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
75.0%
3/4 • Number of events 8 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
4/4 • Number of events 11 • From start of study drug administration up to 30 days after the last dose of study drug
|
60.0%
3/5 • Number of events 7 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 10 • From start of study drug administration up to 30 days after the last dose of study drug
|
36.4%
4/11 • Number of events 9 • From start of study drug administration up to 30 days after the last dose of study drug
|
33.3%
2/6 • Number of events 12 • From start of study drug administration up to 30 days after the last dose of study drug
|
57.1%
8/14 • Number of events 38 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 5 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
33.3%
2/6 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
4/8 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 8 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
33.3%
2/6 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
2/4 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
18.2%
2/11 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
2/4 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
18.2%
2/11 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/14 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/8 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
20.0%
1/5 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/6 • From start of study drug administration up to 30 days after the last dose of study drug
|
14.3%
2/14 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
40.0%
2/5 • Number of events 4 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/11 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
50.0%
2/4 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/5 • From start of study drug administration up to 30 days after the last dose of study drug
|
12.5%
1/8 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
27.3%
3/11 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
35.7%
5/14 • Number of events 9 • From start of study drug administration up to 30 days after the last dose of study drug
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
100.0%
1/1 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/1 • From start of study drug administration up to 30 days after the last dose of study drug
|
0.00%
0/4 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
1/4 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
40.0%
2/5 • Number of events 3 • From start of study drug administration up to 30 days after the last dose of study drug
|
25.0%
2/8 • Number of events 2 • From start of study drug administration up to 30 days after the last dose of study drug
|
9.1%
1/11 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
16.7%
1/6 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
7.1%
1/14 • Number of events 1 • From start of study drug administration up to 30 days after the last dose of study drug
|
Additional Information
Mark Lanasa, MD Associate Director, Clinical Development, Oncology
MedImmune, LLC
Phone: 301-398-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER