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CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00659425
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : October 2, 2017
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Lymphoblastic Leukemia
Non-Hodgkin's Lymphoma
Intervention Drug: CAT-8015 (Moxetumomab Pasudotox)
Enrollment 57
Recruitment Details  
Pre-assignment Details A total of 57 participants were enrolled of which 55 participants received treatment.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
Period Title: Overall Study
Started 1 1 1 4 4 5 8 11 6 14
Completed 0 0 0 0 0 1 0 0 0 1
Not Completed 1 1 1 4 4 4 8 11 6 13
Reason Not Completed
Disease progression             1             0             0             1             0             2             4             3             5             3
Death             0             0             0             1             0             0             1             0             0             0
Adverse Event             0             0             0             0             0             1             0             3             1             4
Investigator Discretion             0             0             0             0             0             1             0             3             0             0
Other             0             1             1             2             4             0             3             2             0             6
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C Total
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 1 1 1 4 4 5 8 11 6 14 55
Hide Baseline Analysis Population Description
Safety Population includes all participants who received any treatment of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 1 participants 4 participants 4 participants 5 participants 8 participants 11 participants 6 participants 14 participants 55 participants
17 [1]   (NA) 8 [1]   (NA) 17 [1]   (NA) 12.8  (6.8) 9  (2.7) 14  (4.7) 8.6  (5.3) 13.8  (6.3) 12.8  (8.3) 14.3  (5.5) 12.7  (5.9)
[1]
Standard Deviation is not evaluable for single participant.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 4 participants 4 participants 5 participants 8 participants 11 participants 6 participants 14 participants 55 participants
Female
1
 100.0%
0
   0.0%
0
   0.0%
3
  75.0%
0
   0.0%
0
   0.0%
3
  37.5%
6
  54.5%
2
  33.3%
6
  42.9%
21
  38.2%
Male
0
   0.0%
1
 100.0%
1
 100.0%
1
  25.0%
4
 100.0%
5
 100.0%
5
  62.5%
5
  45.5%
4
  66.7%
8
  57.1%
34
  61.8%
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities (DLTs)
Hide Description 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.
Time Frame Day 1 up to 21 days of Cycle 1 (each cycle duration was of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 3 4 3 7 7 3 11
Measure Type: Number
Unit of Measure: participants
0 0 0 2 0 1 1 0 1
2.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Hide Description 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.
Time Frame From start of study drug administration until 30 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received any treatment of study drug.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 5 8 11 6 14
Measure Type: Number
Unit of Measure: Participants
TEAEs 1 1 1 4 4 5 8 11 6 14
TESAEs 1 1 1 4 3 2 5 7 4 9
3.Primary Outcome
Title Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hide Description 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.
Time Frame From start of study drug administration until 30 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received any treatment of study drug.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 5 8 11 6 14
Measure Type: Number
Unit of Measure: Participants
Tachycardia 0 0 0 2 3 3 2 2 0 3
Arrhythmia 0 0 0 0 0 0 1 0 0 0
Bradycardia 0 0 0 0 1 1 0 1 0 1
Sinus bradycardia 0 0 0 0 0 0 0 1 0 0
Sinus tachycardia 1 0 0 0 1 0 0 0 0 1
Pyrexia 1 0 0 2 4 2 2 2 2 7
Dyspnoea 0 0 0 0 1 0 0 1 0 4
Respiratory distress 0 0 1 0 0 1 0 0 0 2
Tachypnoea 0 0 0 1 1 0 1 1 0 0
Hypertension 0 1 0 0 2 0 1 3 1 5
Hypotension 0 1 0 0 1 2 2 2 1 1
4.Primary Outcome
Title Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hide Description 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.
Time Frame From start of study drug administration up to 30 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received any treatment of study drug.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 5 8 11 6 14
Measure Type: Number
Unit of Measure: Participants
Febrile neutropenia 0 1 1 1 2 1 3 5 0 1
Anemia 0 1 1 0 0 0 0 0 0 3
Leukopenia 0 0 0 0 0 1 3 0 0 1
Lymphopenia 0 1 1 0 0 1 3 0 0 1
Neutropenia 0 1 0 0 0 1 0 0 0 1
Thrombocytopenia 0 1 1 0 0 1 3 1 0 1
5.Primary Outcome
Title Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
Hide Description 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.
Time Frame From start of study drug administration up to 30 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received any treatment of study drug.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 5 8 11 6 14
Measure Type: Number
Unit of Measure: Participants
Alanine aminotransferase increased 0 1 0 2 0 4 2 2 2 3
Aspartate aminotransferase increased 1 1 1 0 1 3 5 2 4 2
Blood creatinine increased 1 0 1 0 2 0 1 1 1 6
Blood lactate dehydrogenase increased 0 0 0 0 0 0 2 0 3 0
Blood urea increased 0 0 0 0 0 1 2 0 2 0
Hyperglycaemia 0 0 0 0 0 1 3 0 1 2
Hyperphosphataemia 0 0 0 0 0 0 1 1 1 0
Hypoalbuminaemia 0 1 1 0 3 0 1 2 1 2
Hypocalcaemia 0 0 0 0 1 1 0 0 1 1
Hypokalaemia 1 1 1 1 0 2 4 1 0 1
Hypomagnesaemia 0 0 0 0 0 0 1 1 0 1
Hyponatraemia 0 0 1 0 0 0 2 0 2 1
Hypophosphataemia 1 1 0 0 0 0 4 0 1 1
6.Primary Outcome
Title Number of Participants With Abnormalities in Ophthalmologic Examination at End of Treatment That Were Not Present at Baseline
Hide Description 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.
Time Frame Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received any treatment of study drug.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 5 8 11 6 14
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0 0 0 0 0
7.Primary Outcome
Title Number of Participants With Change From Baseline in Normal Sinus Rhythm Findings in ECG
Hide Description Number of participants with abnormal ECG changes (compared with baseline) as assessed by study cardiologist
Time Frame Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received any treatment of study drug.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 4 7 7 6 12
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0 0 0 0 0 0
8.Primary Outcome
Title Change From Baseline to End of Treatment in Clinical Findings in Electrocardiogram (ECG) QT, QTC Interval and Ventricular Rate
Hide Description 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.
Time Frame Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received any treatment of study drug.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 5 8 11 6 14
Mean (Standard Deviation)
Unit of Measure: milli seconds (msec)
QT interval -107 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) -52.0 [3]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
QTC interval 20.0 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) -26.0 [3]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
Ventricluar rate 69.0 [1]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) 29.0 [3]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA)
[1]
Only 1 subject analyzed at baseline and end of treatment so SD is not applicable
[2]
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
[3]
Of the 4 subjects with data, only 1 subject had analyzable data at baseline and end of treatment so SD is not applicable
9.Primary Outcome
Title Best Overall Tumor Response
Hide Description Antitumor activity was assessed by best overall tumor response.
Time Frame Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 4 7 7 6 12
Measure Type: Number
Unit of Measure: Participants
Composite complete response 0 1 0 1 0 1 1 2 2 3
Complete response 0 1 0 1 0 1 1 2 2 3
complete response with incomplete count recovery 0 0 0 0 0 0 0 0 0 0
Partial response 0 0 0 0 0 1 0 1 0 2
Hematological activity 0 0 0 2 3 0 3 1 1 2
Stable disease 0 0 1 1 1 1 2 1 0 4
Progressive disease 1 0 0 0 0 1 1 2 3 1
10.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description 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)].
Time Frame Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 4 7 7 6 12
Measure Type: Number
Unit of Measure: percentage of participants
0 100 0 25.0 0 50.0 14.3 42.9 33.3 41.7
11.Primary Outcome
Title Percentage of Participants With Relapse of Disease
Hide Description 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.
Time Frame Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 0 1 0 1 0 1 1 1 2 3
Measure Type: Number
Unit of Measure: percentage of participants
0 100 0 0 0 50 0
12.Primary Outcome
Title Time to Disease Response
Hide Description 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.
Time Frame Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 0 1 0 1 0 2 1 3 2 5
Median (Full Range)
Unit of Measure: months
0.69
(0.69 to 0.69)
0.49
(0.49 to 0.49)
0.66
(0.59 to 0.72)
0.49
(0.49 to 0.49)
0.72
(0.72 to 0.76)
0.62
(0.59 to 0.66)
0.66
(0.59 to 0.72)
13.Primary Outcome
Title Duration of Response (DR)
Hide Description Duration of response was defined as the duration from the first documentation of objective response to the first documented disease progression.
Time Frame Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 0 1 0 1 0 2 1 3 2 5
Median (Full Range)
Unit of Measure: months
NA [1] 
(1.9 to 1.9)
2.3
(2.3 to 2.3)
NA [1] 
(0.7 to 1.4)
NA [1] 
(0.8 to 0.8)
NA [1] 
(0.0 to 0.9)
NA [1] 
(0.4 to 1.4)
NA [1] 
(0.0 to 2.0)
[1]
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)
14.Primary Outcome
Title Time to Disease Progression (TDP)
Hide Description 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.
Time Frame Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 4 7 7 6 12
Median (Full Range)
Unit of Measure: months
0.2
(0.2 to 0.2)
NA [1] 
(2.6 to 2.6)
NA [1] 
(0.6 to 0.6)
2
(0.5 to 2.8)
NA [1] 
(0.2 to 1.4)
NA [1] 
(0.5 to 2.2)
1.2
(0.5 to 1.2)
1.5
(0.5 to 1.6)
0.8
(0.4 to 2.0)
NA [1] 
(0.5 to 2.7)
[1]
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)
15.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description 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.
Time Frame Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 4 7 7 6 12
Median (Full Range)
Unit of Measure: months
0.2
(0.2 to 0.2)
3.6
(3.6 to 3.6)
1.7
(1.7 to 1.7)
1.8
(0.6 to 2.8)
NA [1] 
(0.2 to 1.4)
3.1
(0.5 to 9.0)
1.2
(0.6 to 14.0)
1.5
(0.5 to 5.6)
0.8
(0.4 to 5.9)
5.8
(0.5 to 17.3)
[1]
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)
16.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was determined as the time from the start of treatment with Moxetumomab Pasudotox until death. Number of deaths were reported here.
Time Frame Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 4 7 7 6 12
Median (Full Range)
Unit of Measure: months
0.2
(0.2 to 0.2)
3.6
(3.6 to 3.6)
1.7
(1.7 to 1.7)
2.1
(0.6 to 31.3)
NA [1] 
(0.7 to 1.4)
4.6
(1.6 to 9.0)
9.4
(1.8 to 42.0)
NA [1] 
(1.7 to 13.7)
4.1
(0.9 to 7.9)
12.7
(1.9 to 26.1)
[1]
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)
17.Primary Outcome
Title Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox
Hide Description The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.
Time Frame 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 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg) 30 Microgram Per Kilogram (mcg/kg) 32 Microgram Per Kilogram (mcg/kg): Schema C 40 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg)
Hide Arm/Group Description:
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.
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.
Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
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.
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.
Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Overall Number of Participants Analyzed 1 1 5 9 10 6 20
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
NA [1]   (NA) 126 [2]   (NA) 274  (135) 446  (126) 446  (156) 555  (196) 755  (188)
[1]
Cmax below lower limit of quantification
[2]
Standard deviation was not evaluable since only 1 participant was evaluated.
18.Primary Outcome
Title Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUC [0 to Infinity]) for Moxetumomab Pasudotox
Hide Description The AUC (0 to infinity) is the area under the plasma concentration-time curve from time zero to infinity hours.
Time Frame 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 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg) 30 Microgram Per Kilogram (mcg/kg) 32 Microgram Per Kilogram (mcg/kg): Schema C 40 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg)
Hide Arm/Group Description:
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.
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.
Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
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.
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.
Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Overall Number of Participants Analyzed 1 1 3 8 10 5 20
Mean (Standard Deviation)
Unit of Measure: hour*nanogram per milliliter (h.ng/mL)
NA [1]   (NA) NA [1]   (NA) 744  (514) 1060  (508) 844  (385) 1320  (554) 1690  (689)
[1]
AUC cannot be estimated due to insufficient samples from subject to be able to calculate AUC
19.Primary Outcome
Title Systemic Clearance (CL) for Moxetumomab Pasudotox
Hide Description 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]).
Time Frame 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 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg) 30 Microgram Per Kilogram (mcg/kg) 32 Microgram Per Kilogram (mcg/kg): Schema C 40 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg)
Hide Arm/Group Description:
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.
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.
Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
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.
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.
Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Overall Number of Participants Analyzed 1 1 3 8 10 5 20
Mean (Standard Deviation)
Unit of Measure: milliliter per hour per kilogram
NA [1]   (NA) NA [1]   (NA) 40.5  (32.3) 35.4  (18.2) 47.5  (28.2) 34.6  (13.2) 35.3  (14.7)
[1]
CL below lower limit of quantification
20.Primary Outcome
Title Terminal Phase Elimination Half Life (t1/2) for Moxetumomab Pasudotox
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 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 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg) 30 Microgram Per Kilogram (mcg/kg) 32 Microgram Per Kilogram (mcg/kg): Schema C 40 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg)
Hide Arm/Group Description:
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.
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.
Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
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.
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.
Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Overall Number of Participants Analyzed 1 1 3 8 10 5 20
Mean (Standard Deviation)
Unit of Measure: hour (h)
NA [1]   (NA) NA [1]   (NA) 0.906  (0.545) 1.32  (0.893) 0.997  (0.557) 0.880  (0.522) 1.38  (0.753)
[1]
plasma concentration of moxetumomab pasudotox below the lower limit of quantification therefore t1/2 cannot be estimated
21.Secondary Outcome
Title Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody
Hide Description 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.
Time Frame Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received any treatment of study drug.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 5 8 11 6 14
Measure Type: Number
Unit of Measure: Participants
ADA present by screening assay 0 0 0 1 1 1 1 1 1 1
Neutralizing ADA present by functional assay 1 0 0 0 0 1 1 5 0 3
22.Secondary Outcome
Title CD22 Expression Cells in Peripheral Blood by Best Response
Hide Description Participants malignant cells (peripheral blood) was tested for cluster of differentiation 22 (CD22) expression by fluorescence-activated cell sorter (FACS) analysis.
Time Frame Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received any treatment of study drug. Here, n = participants evaluable for specified category for each arm, respectively
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 5 8 11 6 14
Median (Full Range)
Unit of Measure: sites per cell
Composite complete response(n=0,1,0,1,0,1,0,2,2,3)
NA [1] 
(NA to NA)
14519.0
(14519 to 14519)
NA [1] 
(NA to NA)
749.0
(749 to 749)
NA [1] 
(NA to NA)
3058.0
(3058 to 3058)
NA [1] 
(NA to NA)
2772.5
(1650 to 3895)
5620.0
(3968 to 7272)
4331.0
(3085 to 10393)
Complete response (n=0,1,0,1,0,1,0,2,2,3)
NA [1] 
(NA to NA)
14519.0
(14519 to 14519)
NA [1] 
(NA to NA)
749.0
(749 to 749)
NA [1] 
(NA to NA)
3058.0
(3058 to 3058)
NA [1] 
(NA to NA)
2772.5
(1650 to 3895)
5620.0
(3968 to 7272)
4331.0
(3085 to 10393)
Partial response (n=0,0,0,0,0,1,0,1,0,2)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
2387.0
(2387 to 2387)
NA [1] 
(NA to NA)
4514.0
(4514 to 4514)
NA [1] 
(NA to NA)
2366.0
(2312 to 2420)
Hematological activity (n=0,0,0,2,3,0,3,1,1,2)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
3533.5
(2214 to 4853)
2476.0
(1851 to 4821)
NA [1] 
(NA to NA)
1427.0
(1194 to 4391)
1350.0
(1350 to 1350)
2642.0
(2642 to 2642)
2223.5
(1616 to 2831)
Stable response (n=0,0,1,1,1,1,2,1,0,4)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
5050.0
(5050 to 5050)
8083.0
(8083 to 8083)
2111.0
(2111 to 2111)
5587.0
(5587 to 5587)
8513.0
(3045 to 13981)
2521.0
(2521 to 2521)
NA [1] 
(NA to NA)
3904.0
(1226 to 11435)
Progressive disease (n=1,0,0,0,0,1,1,2,3,1)
13210.0
(13210 to 13210)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
3705.0
(3705 to 3705)
1415.0
(1415 to 1415)
5505.5
(1354 to 9657)
1643.0
(1387 to 5359)
3102.0
(3102 to 3102)
[1]
No participants were evaluated.
23.Secondary Outcome
Title Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Hide Description Potential biomarkers include orthostatic blood pressure, albumin levels, weight change, edema and hypoxia were evaluated.
Time Frame Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received any treatment of study drug.
Arm/Group Title 5 Microgram Per Kilogram (mcg/kg) 10 Microgram Per Kilogram (mcg/kg) 20 Microgram Per Kilogram (mcg/kg): Schema A 20 Microgram Per Kilogram (mcg/kg): Schema B 30 Microgram Per Kilogram (mcg/kg): Schema A 30 Microgram Per Kilogram (mcg/kg): Schema B 40 Microgram Per Kilogram (mcg/kg): Schema B 32 Microgram Per Kilogram (mcg/kg): Schema C 50 Microgram Per Kilogram (mcg/kg): Schema B 50 Microgram Per Kilogram (mcg/kg): Schema C
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 1 1 1 4 4 5 8 11 6 14
Measure Type: Number
Unit of Measure: participants
Hypertension; Event; Developed no later than CLS 0 0 0 0 0 0 0 0 0 0
Hypertension; Event; Developed after CLS 0 0 0 0 2 0 0 0 0 0
Hypertension; Event; No CLS 0 0 0 0 0 0 0 2 1 5
Hypertension; No Event; No CLS 1 1 1 4 2 4 8 9 5 8
Hypertension; No Event; CLS 0 0 0 0 0 1 0 0 0 1
Weight change; Event; Developed no later than CLS 0 0 0 0 1 0 0 0 0 0
Weight change; Event; Developed after CLS 0 0 0 0 0 0 0 0 0 0
Weight change; Event; No CLS 0 0 0 2 0 1 0 3 0 3
Weight change; No Event; No CLS 1 1 1 2 2 3 8 8 6 10
Weight change; No Event; CLS 0 0 0 0 1 1 0 0 0 1
Change in Albumin; Event; Developed no later CLS 0 0 0 0 0 0 0 0 0 0
Change in Albumin; Event; Developed after CLS 0 0 0 0 0 0 0 0 0 0
Change in Albumin; Event; No CLS 0 0 0 0 0 1 0 0 0 1
Change in Albumin; No Event; No CLS 1 1 1 4 2 3 8 11 6 13
Change in Albumin; No Event; CLS 0 0 0 0 2 1 0 0 0 1
Edema; Event; Developed no later than CLS 0 0 0 0 0 1 0 0 0 0
Edema; Event; Developed after CLS 0 0 0 0 0 0 0 0 0 0
Edema; Event; No CLS 0 0 0 0 0 0 0 0 0 0
Edema; No Event; No CLS 1 1 1 4 2 4 8 11 6 13
Edema; No Event; CLS 0 0 0 0 2 0 0 0 0 1
Hypoxia; Event; Developed no later than CLS 0 0 0 0 1 0 0 0 0 0
Hypoxia; Event; Developed after CLS 0 0 0 0 1 1 0 0 0 0
Hypoxia; Event; No CLS 1 0 1 1 0 0 1 2 2 1
Hypoxia; No Event; No CLS 0 1 0 3 2 4 7 9 4 12
Hypoxia; No Event; CLS 0 0 0 0 0 0 0 0 0 1
Time Frame From start of study drug administration up to 30 days after the last dose of study drug
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 5 UG/KG SCHEMA A 10 UG/KG SCHEMA A 20 UG/KG SCHEMA A 20 UG/KG SCHEMA B 30 UG/KG SCHEMA A 30 UG/KG SCHEMA B 40 UG/KG SCHEMA B 32 UG/KG SCHEMA C 50 UG/KG SCHEMA B 50 UG/KG SCHEMA C
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
All-Cause Mortality
5 UG/KG SCHEMA A 10 UG/KG SCHEMA A 20 UG/KG SCHEMA A 20 UG/KG SCHEMA B 30 UG/KG SCHEMA A 30 UG/KG SCHEMA B 40 UG/KG SCHEMA B 32 UG/KG SCHEMA C 50 UG/KG SCHEMA B 50 UG/KG SCHEMA C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
5 UG/KG SCHEMA A 10 UG/KG SCHEMA A 20 UG/KG SCHEMA A 20 UG/KG SCHEMA B 30 UG/KG SCHEMA A 30 UG/KG SCHEMA B 40 UG/KG SCHEMA B 32 UG/KG SCHEMA C 50 UG/KG SCHEMA B 50 UG/KG SCHEMA C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      4/4 (100.00%)      3/4 (75.00%)      2/5 (40.00%)      5/8 (62.50%)      7/11 (63.64%)      4/6 (66.67%)      9/14 (64.29%)    
Blood and lymphatic system disorders                     
Febrile neutropenia  1  0/1 (0.00%)  0 1/1 (100.00%)  2 1/1 (100.00%)  2 1/4 (25.00%)  1 0/4 (0.00%)  0 1/5 (20.00%)  2 2/8 (25.00%)  3 1/11 (9.09%)  2 0/6 (0.00%)  0 0/14 (0.00%)  0
Haemolytic uraemic syndrome  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 3/14 (21.43%)  3
Thrombocytopenia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 0/14 (0.00%)  0
Cardiac disorders                     
Cardiac arrest  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/8 (12.50%)  1 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Eye disorders                     
Choroidal detachment  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Gastrointestinal disorders                     
Upper gastrointestinal haemorrhage  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Colitis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 0/14 (0.00%)  0
General disorders                     
Brain death  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1
Multi-organ failure  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 1/11 (9.09%)  1 1/6 (16.67%)  1 0/14 (0.00%)  0
Pyrexia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 1/4 (25.00%)  1 0/5 (0.00%)  0 2/8 (25.00%)  2 1/11 (9.09%)  1 0/6 (0.00%)  0 0/14 (0.00%)  0
Disease progression  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/8 (12.50%)  1 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Hepatobiliary disorders                     
Hepatobiliary disease  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 0/14 (0.00%)  0
Venoocclusive liver disease  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1
Infections and infestations                     
Bacteraemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Bacterial infection  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  2 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Geotrichum infection  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1
Herpes zoster  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1
Opportunistic infection  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Pneumonia fungal  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Sepsis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0
Staphylococcal sepsis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 0/14 (0.00%)  0
Neutropenic infection  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/8 (12.50%)  1 1/11 (9.09%)  1 0/6 (0.00%)  0 2/14 (14.29%)  2
Septic shock  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  2 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 0/14 (0.00%)  0
Systemic mycosis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Tooth infection  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/8 (12.50%)  1 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Investigations                     
Blood creatinine increased  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 2/14 (14.29%)  2
Aspartate aminotransferase increased  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Troponin  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/8 (12.50%)  1 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Metabolism and nutrition disorders                     
Hypercalcaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/8 (12.50%)  2 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Acute lymphocytic leukaemia recurrent  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1
Leukaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0
Nervous system disorders                     
Central nervous system haemorrhage  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1
Coma  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Seizure  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1 0/8 (0.00%)  0 0/11 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0
Renal and urinary disorders                     
Haemoglobinuria  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 0/14 (0.00%)  0
Proteinuria  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 0/14 (0.00%)  0
Renal failure  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 2/14 (14.29%)  2
Respiratory, thoracic and mediastinal disorders                     
Hypoxia  1  1/1 (100.00%)  1 0/1 (0.00%)  0 1/1 (100.00%)  1 0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 1/8 (12.50%)  1 0/11 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0
Lung infiltration  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0
Pleural effusion  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 2/4 (50.00%)  3 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Pneumonitis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  3 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Pulmonary haemorrhage  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 0/14 (0.00%)  0
Acute respiratory distress syndrome  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1
Dyspnoea  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 0/14 (0.00%)  0
Epistaxis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 0/14 (0.00%)  0
Respiratory distress  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Vascular disorders                     
Capillary leak syndrome  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 2/4 (50.00%)  2 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1
Haemorrhage  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Hypotension  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 0/14 (0.00%)  0
Thrombosis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0
Venoocclusive disease  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
5 UG/KG SCHEMA A 10 UG/KG SCHEMA A 20 UG/KG SCHEMA A 20 UG/KG SCHEMA B 30 UG/KG SCHEMA A 30 UG/KG SCHEMA B 40 UG/KG SCHEMA B 32 UG/KG SCHEMA C 50 UG/KG SCHEMA B 50 UG/KG SCHEMA C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      4/4 (100.00%)      4/4 (100.00%)      5/5 (100.00%)      8/8 (100.00%)      11/11 (100.00%)      6/6 (100.00%)      14/14 (100.00%)    
Blood and lymphatic system disorders                     
Anaemia  1  0/1 (0.00%)  0 1/1 (100.00%)  19 1/1 (100.00%)  12 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 2/8 (25.00%)  12 0/11 (0.00%)  0 0/6 (0.00%)  0 3/14 (21.43%)  17
Febrile neutropenia  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 2/4 (50.00%)  2 0/5 (0.00%)  0 2/8 (25.00%)  2 4/11 (36.36%)  4 0/6 (0.00%)  0 2/14 (14.29%)  2
Leukopenia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  3 3/8 (37.50%)  7 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  12
Lymphopenia  1  0/1 (0.00%)  0 1/1 (100.00%)  13 1/1 (100.00%)  4 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  4 3/8 (37.50%)  7 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  10
Neutropenia  1  0/1 (0.00%)  0 1/1 (100.00%)  7 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  7
Thrombocytopenia  1  0/1 (0.00%)  0 1/1 (100.00%)  38 1/1 (100.00%)  8 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  12 3/8 (37.50%)  24 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  15
Cardiac disorders                     
Sinus tachycardia  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  2
Tachycardia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/4 (50.00%)  3 3/4 (75.00%)  3 3/5 (60.00%)  4 2/8 (25.00%)  2 2/11 (18.18%)  2 0/6 (0.00%)  0 3/14 (21.43%)  4
Bradycardia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 1/5 (20.00%)  1 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 1/14 (7.14%)  1
Pericardial effusion  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  1
Eye disorders                     
Vision blurred  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 3/11 (27.27%)  3 0/6 (0.00%)  0 3/14 (21.43%)  3
Gastrointestinal disorders                     
Abdominal pain  1  0/1 (0.00%)  0 1/1 (100.00%)  4 1/1 (100.00%)  1 1/4 (25.00%)  1 1/4 (25.00%)  1 3/5 (60.00%)  3 2/8 (25.00%)  2 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Colitis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/8 (12.50%)  1 0/11 (0.00%)  0 1/6 (16.67%)  1 0/14 (0.00%)  0
Constipation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 1/5 (20.00%)  1 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 3/14 (21.43%)  3
Diarrhoea  1  0/1 (0.00%)  0 1/1 (100.00%)  2 1/1 (100.00%)  3 0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 3/8 (37.50%)  5 4/11 (36.36%)  4 1/6 (16.67%)  1 2/14 (14.29%)  2
Nausea  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 1/4 (25.00%)  1 2/4 (50.00%)  7 0/5 (0.00%)  0 4/8 (50.00%)  7 2/11 (18.18%)  2 0/6 (0.00%)  0 5/14 (35.71%)  6
Stomatitis  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  4 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1 0/8 (0.00%)  0 0/11 (0.00%)  0 0/6 (0.00%)  0 2/14 (14.29%)  2
Vomiting  1  0/1 (0.00%)  0 1/1 (100.00%)  4 1/1 (100.00%)  3 1/4 (25.00%)  1 1/4 (25.00%)  1 0/5 (0.00%)  0 2/8 (25.00%)  5 2/11 (18.18%)  2 0/6 (0.00%)  0 3/14 (21.43%)  4
Dyspepsia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  2 1/8 (12.50%)  2 0/11 (0.00%)  0 0/6 (0.00%)  0 2/14 (14.29%)  2
Oral pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 2/14 (14.29%)  3
General disorders                     
Catheter site pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 3/11 (27.27%)  3 0/6 (0.00%)  0 2/14 (14.29%)  2
Fatigue  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 3/5 (60.00%)  3 0/8 (0.00%)  0 4/11 (36.36%)  4 1/6 (16.67%)  2 5/14 (35.71%)  5
Oedema  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 1/4 (25.00%)  1 2/5 (40.00%)  3 1/8 (12.50%)  1 2/11 (18.18%)  2 1/6 (16.67%)  2 4/14 (28.57%)  7
Oedema peripheral  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/8 (0.00%)  0 4/11 (36.36%)  5 1/6 (16.67%)  1 4/14 (28.57%)  6
Pyrexia  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 3/4 (75.00%)  3 2/5 (40.00%)  2 0/8 (0.00%)  0 2/11 (18.18%)  3 2/6 (33.33%)  5 7/14 (50.00%)  15
Hepatobiliary disorders                     
Hyperbilirubinaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  2 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/8 (12.50%)  1 0/11 (0.00%)  0 0/6 (0.00%)  0 1/14 (7.14%)  6
Infections and infestations                     
Sinusitis  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/8 (12.50%)  1 1/11 (9.09%)  1 0/6 (0.00%)  0 2/14 (14.29%)  2
Investigations                     
Activated partial thromboplastin time prolonged  1  0/1 (0.00%)  0 1/1 (100.00%)  3 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 2/8 (25.00%)  2 0/11 (0.00%)  0 0/6 (0.00%)  0 0/14 (0.00%)  0
Alanine aminotransferase increased  1  0/1 (0.00%)  0 1/1 (100.00%)  2 0/1 (0.00%)  0 2/4 (50.00%)  2 0/4 (0.00%)  0 4/5 (80.00%)  8 2/8 (25.00%)  10 2/11 (18.18%)  3 2/6 (33.33%)  6 3/14 (21.43%)  8
Aspartate aminotransferase increased  1  1/1 (100.00%)  1 1/1 (100.00%)  2 1/1 (100.00%)  1 0/4 (0.00%)  0 1/4 (25.00%)  1 3/5 (60.00%)  5 5/8 (62.50%)  10 2/11 (18.18%)  2 4/6 (66.67%)  7 2/14 (14.29%)  5
Blood lactate dehydrogenase increased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 2/8 (25.00%)  2 0/11 (0.00%)  0 3/6 (50.00%)  5 0/14 (0.00%)  0
Blood urea increased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1 2/8 (25.00%)  4 0/11 (0.00%)  0 2/6 (33.33%)  3 0/14 (0.00%)  0
Electrocardiogram qt prolonged  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1 0/8 (0.00%)  0 0/11 (0.00%)  0 1/6 (16.67%)  1 1/14 (7.14%)  1
Neutrophil count decreased  1  0/1 (0.00%)  0 1/1 (100.00%)  2 1/1 (100.00%)  1 1/4 (25.00%)  3 3/4 (75.00%)  20 2/5 (40.00%)  11 2/8 (25.00%)  3 3/11 (27.27%)  5 1/6 (16.67%)  3 8/14 (57.14%)  17
Platelet count decreased  1  0/1 (0.00%)  0 1/1 (100.00%)  2 0/1 (0.00%)  0 1/4 (25.00%)  2 4/4 (100.00%)  23 4/5 (80.00%)  33 3/8 (37.50%)  25 6/11 (54.55%)  39 4/6 (66.67%)  17 7/14 (50.00%)  37
Weight increased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 4/4 (100.00%)  8 2/4 (50.00%)  6 2/5 (40.00%)  4 0/8 (0.00%)  0 7/11 (63.64%)  15 3/6 (50.00%)  4 4/14 (28.57%)  15
White blood cell count decreased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 3/4 (75.00%)  16 2/4 (50.00%)  10 3/5 (60.00%)  5 1/8 (12.50%)  8 4/11 (36.36%)  8 2/6 (33.33%)  11 8/14 (57.14%)  43
Blood creatinine increased  1  1/1 (100.00%)  2 0/1 (0.00%)  0 1/1 (100.00%)  1 0/4 (0.00%)  0 2/4 (50.00%)  2 0/5 (0.00%)  0 1/8 (12.50%)  1 1/11 (9.09%)  1 1/6 (16.67%)  3 6/14 (42.86%)  13
Haemoglobin decreased  1  1/1 (100.00%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0 3/4 (75.00%)  8 4/4 (100.00%)  11 3/5 (60.00%)  7 2/8 (25.00%)  10 4/11 (36.36%)  9 2/6 (33.33%)  12 8/14 (57.14%)  38
Metabolism and nutrition disorders                     
Decreased appetite  1  0/1 (0.00%)  0 1/1 (100.00%)  2 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 2/8 (25.00%)  2 1/11 (9.09%)  1 0/6 (0.00%)  0 0/14 (0.00%)  0
Hyperglycaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  3 3/8 (37.50%)  5 0/11 (0.00%)  0 1/6 (16.67%)  1 2/14 (14.29%)  13
Hyperphosphataemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/8 (12.50%)  3 1/11 (9.09%)  1 1/6 (16.67%)  1 0/14 (0.00%)  0
Hypoalbuminaemia  1  0/1 (0.00%)  0 1/1 (100.00%)  1 1/1 (100.00%)  4 0/4 (0.00%)  0 3/4 (75.00%)  7 0/5 (0.00%)  0 1/8 (12.50%)  1 2/11 (18.18%)  2 1/6 (16.67%)  2 2/14 (14.29%)  4
Hypocalcaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 1/5 (20.00%)  2 0/8 (0.00%)  0 0/11 (0.00%)  0 1/6 (16.67%)  1 1/14 (7.14%)  6
Hypokalaemia  1  1/1 (100.00%)  1 1/1 (100.00%)  3 1/1 (100.00%)  2 1/4 (25.00%)  3 0/4 (0.00%)  0 2/5 (40.00%)  3 4/8 (50.00%)  5 1/11 (9.09%)  3 0/6 (0.00%)  0 1/14 (7.14%)  4
Hypomagnesaemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/8 (12.50%)  1 1/11 (9.09%)  1 0/6 (0.00%)  0 1/14 (7.14%)  5
Hyponatraemia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 2/8 (25.00%)  3 0/11 (0.00%)  0 2/6 (33.33%)  2 1/14 (7.14%)  1
Hypophosphataemia  1  1/1 (100.00%)  1 1/1 (100.00%)  2 0/1 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 4/8 (50.00%)  4 0/11 (0.00%)  0 1/6 (16.67%)  1 1/14 (7.14%)  8
Musculoskeletal and connective tissue disorders                     
Bone pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0