Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs
Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia · Source last updated 2020-04-08
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months)
What was measured
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 AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 30 days after the last dose of study drug (approximately 7 months).
Analysis population: Safety population included participants who received at least 1 dose of moxetumomab pasudotox.
Groups in this outcome
Moxetumomab Pasudotox 40 µg/kg
Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Moxetumomab Pasudotox 40 µg/kg
80
Reported measurements
Anaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
17
Not reported
Not reported
Not reported
Not reported
Disseminated intravascular coagulation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
1
Not reported
Not reported
Not reported
Not reported
Febrile neutropenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
5
Not reported
Not reported
Not reported
Not reported
Iron deficiency anaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
1
Not reported
Not reported
Not reported
Not reported
Leukopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
2
Not reported
Not reported
Not reported
Not reported
Lymphopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
1
Not reported
Not reported
Not reported
Not reported
Neutropenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
4
Not reported
Not reported
Not reported
Not reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
3
Not reported
Not reported
Not reported
Not reported
Activated partial thromboplastin time prolonged
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
1
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
16
Not reported
Not reported
Not reported
Not reported
Lymphocyte count increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
1
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
6
Not reported
Not reported
Not reported
Not reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
9
Not reported
Not reported
Not reported
Not reported
White blood cell count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
8
Not reported
Not reported
Not reported
Not reported
Aspartate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
15
Not reported
Not reported
Not reported
Not reported
Blood albumin decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
1
Not reported
Not reported
Not reported
Not reported
Blood alkaline phosphatase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
4
Not reported
Not reported
Not reported
Not reported
Blood bicarbonate decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
2
Not reported
Not reported
Not reported
Not reported
Blood bilirubin increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
5
Not reported
Not reported
Not reported
Not reported
Blood creatinine increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
9
Not reported
Not reported
Not reported
Not reported
Blood triglycerides increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
1
Not reported
Not reported
Not reported
Not reported
Gamma-glutamyltransferase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
1
Not reported
Not reported
Not reported
Not reported
Lipase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
2
Not reported
Not reported
Not reported
Not reported
Hyperglycaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
8
Not reported
Not reported
Not reported
Not reported
Hyperkalaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
6
Not reported
Not reported
Not reported
Not reported
Hypermagnesaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
3
Not reported
Not reported
Not reported
Not reported
Hypernatraemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
4
Not reported
Not reported
Not reported
Not reported
Hypertriglyceridaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
2
Not reported
Not reported
Not reported
Not reported
Hypoalbuminaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
16
Not reported
Not reported
Not reported
Not reported
Hypocalcaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
19
Not reported
Not reported
Not reported
Not reported
Hypoglycaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
2
Not reported
Not reported
Not reported
Not reported
Hypokalaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
13
Not reported
Not reported
Not reported
Not reported
Hypomagnesaemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
6
Not reported
Not reported
Not reported
Not reported
Hyponatraemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
9
Not reported
Not reported
Not reported
Not reported
Haematuria
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
6
Not reported
Not reported
Not reported
Not reported
Haemoglobinuria
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
2
Not reported
Not reported
Not reported
Not reported
Proteinuria
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Moxetumomab Pasudotox 40 µg/kg
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
17
title
Anaemia
categories
measurements
group Id
OG000
value
1
title
Disseminated intravascular coagulation
categories
measurements
group Id
OG000
value
5
title
Febrile neutropenia
categories
measurements
group Id
OG000
value
1
title
Iron deficiency anaemia
categories
measurements
group Id
OG000
value
2
title
Leukopenia
categories
measurements
group Id
OG000
value
1
title
Lymphopenia
categories
measurements
group Id
OG000
value
4
title
Neutropenia
categories
measurements
group Id
OG000
value
3
title
Thrombocytopenia
categories
measurements
group Id
OG000
value
1
title
Activated partial thromboplastin time prolonged
categories
measurements
group Id
OG000
value
16
title
Lymphocyte count decreased
categories
measurements
group Id
OG000
value
1
title
Lymphocyte count increased
categories
measurements
group Id
OG000
value
6
title
Neutrophil count decreased
denoms
counts
group Id
OG000
value
80
units
Participants
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 AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 30 days after the last dose of study drug (approximately 7 months).
groups
description
Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.
id
OG000
title
Moxetumomab Pasudotox 40 µg/kg
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population included participants who received at least 1 dose of moxetumomab pasudotox.
reporting Status
POSTED
time Frame
From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months)
title
Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs
Triangle