NCT00586924 · OUTCOME

Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)

A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia · Source last updated 2019-04-02

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 start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)

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 an adverse event.

Analysis population: Safety population included all participants who received any treatment of moxetumomab pasudotox.

Groups in this outcome

5 mcg/kg

Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

10 mcg/kg

Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

20 mcg/kg

Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

30 mcg/kg

Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

40 mcg/kg

Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

50 mcg/kg

Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

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
5 mcg/kg	3
10 mcg/kg	3
20 mcg/kg	3
30 mcg/kg	3
40 mcg/kg	4
50 mcg/kg	33

Reported measurements

Alanine aminotransferase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	3	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	25	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	24	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
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	5	Not reported	Not reported	Not reported	Not reported

Blood bicarbonate decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	5	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	2	Not reported	Not reported	Not reported	Not reported

Blood creatine phosphokinase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	4	Not reported	Not reported	Not reported	Not reported

Blood creatinine increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	11	Not reported	Not reported	Not reported	Not reported

Blood triglycerides increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	2	Not reported	Not reported	Not reported	Not reported

Gamma-glutamyltransferase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	7	Not reported	Not reported	Not reported	Not reported

Blood uric acid increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	1	Not reported	Not reported	Not reported	Not reported

Hyperglycaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	13	Not reported	Not reported	Not reported	Not reported

Hypermagnesaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	12	Not reported	Not reported	Not reported	Not reported

Hypernatraemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	6	Not reported	Not reported	Not reported	Not reported

Hypertriglyceridaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	19	Not reported	Not reported	Not reported	Not reported

Hyperuricaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	4	Not reported	Not reported	Not reported	Not reported

Hypoalbuminaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	3	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	3	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	25	Not reported	Not reported	Not reported	Not reported

Hypocalcaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	11	Not reported	Not reported	Not reported	Not reported

Hypoglycaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	1	Not reported	Not reported	Not reported	Not reported

Hypokalaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	2	Not reported	Not reported	Not reported	Not reported

Hypomagnesaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	7	Not reported	Not reported	Not reported	Not reported

Hyponatraemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	3	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	7	Not reported	Not reported	Not reported	Not reported

Hypophosphataemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	10	Not reported	Not reported	Not reported	Not reported

Hemoglobin urine

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	0	Not reported	Not reported	Not reported	Not reported

Protein urine

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	1	Not reported	Not reported	Not reported	Not reported

Proteinuria

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	9	Not reported	Not reported	Not reported	Not reported

Hemoglobinuria

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	3	Not reported	Not reported	Not reported	Not reported

Hypercholesterolaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	9	Not reported	Not reported	Not reported	Not reported

Hyperkalaemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	5	Not reported	Not reported	Not reported	Not reported

Lymphopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	25	Not reported	Not reported	Not reported	Not reported

White blood cell count decresed

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	17	Not reported	Not reported	Not reported	Not reported

Lymphocyte count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	5	Not reported	Not reported	Not reported	Not reported

Neutrophil count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	10	Not reported	Not reported	Not reported	Not reported

Hemoglobin decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	9	Not reported	Not reported	Not reported	Not reported

Platelet count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	2	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	6	Not reported	Not reported	Not reported	Not reported

Haptoglobin decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
10 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
20 mcg/kg	0	Not reported	Not reported	Not reported	Not reported
30 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
40 mcg/kg	1	Not reported	Not reported	Not reported	Not reported
50 mcg/kg	7	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
3
group Id
OG004
value
2
group Id
OG005
value
25
title
Alanine aminotransferase increased
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
24
title
Aspartate aminotransferase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
5
title
Blood alkaline phosphatase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
5
title
Blood bicarbonate decreased
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
2
title
Blood bilirubin increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
4
title
Blood creatine phosphokinase increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
11
title
Blood creatinine increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
1
group Id
OG005
value
2
title
Blood triglycerides increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
7
title
Gamma-glutamyltransferase increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
1
title
Blood uric acid increased
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
2
group Id
OG004
value
2
group Id
OG005
value
13
title
Hyperglycaemia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
12
title
Hypermagnesaemia

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
4
group Id
OG005
value
33
units
Participants

description

groups

description
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG000
title
5 mcg/kg
description
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG001
title
10 mcg/kg
description
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG002
title
20 mcg/kg
description
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG003
title
30 mcg/kg
description
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG004
title
40 mcg/kg
description
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG005
title
50 mcg/kg

param Type

COUNT_OF_PARTICIPANTS

population Description

Safety population included all participants who received any treatment of moxetumomab pasudotox.

reporting Status

POSTED

time Frame

From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)

title

Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice