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NCT03219333 · OUTCOME

Number of Participants With Treatment-Emergent Laboratory Abnormalities (Serum Chemistry)

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer · Source last updated 2024-08-27

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: The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months]

What was measured

A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose. Abnormalities were graded based NCI CTCAE version 4.03 - Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.

Analysis population: Safety Analysis set. Here 'Number Analyzed' for each laboratory parameter is based on the number of participants who received at least one dose of enfortumab vedotin and have a baseline and post-baseline laboratory value.

Groups in this outcome

Enfortumab Vedotin - Cohort 1

Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

Enfortumab Vedotin - Cohort 2

Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

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
Enfortumab Vedotin - Cohort 1	125
Enfortumab Vedotin - Cohort 2	89

Reported measurements

Alanine aminotransferase increased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	34	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	26	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	89

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	1	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	0	Not reported	Not reported	Not reported	Not reported

Albumin decreased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	38	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	16	Not reported	Not reported	Not reported	Not reported

Albumin decreased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	89

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	1	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	0	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase increased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	21	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	12	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase increased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	1	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	0	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	121
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	79	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	52	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	121
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	3	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	2	Not reported	Not reported	Not reported	Not reported

Bilirubin increased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	13	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	5	Not reported	Not reported	Not reported	Not reported

Bilirubin increased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	89

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	1	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	0	Not reported	Not reported	Not reported	Not reported

Calcium decreased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	15	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	7	Not reported	Not reported	Not reported	Not reported

Calcium decreased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	125
Enfortumab Vedotin - Cohort 2	89

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	0	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	0	Not reported	Not reported	Not reported	Not reported

Calcium increased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	1	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	7	Not reported	Not reported	Not reported	Not reported

Calcium increased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	125
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	0	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	3	Not reported	Not reported	Not reported	Not reported

Creatinine increased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	73	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	46	Not reported	Not reported	Not reported	Not reported

Creatinine increased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	2	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	3	Not reported	Not reported	Not reported	Not reported

Glucose decreased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	32	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	26	Not reported	Not reported	Not reported	Not reported

Glucose decreased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	125
Enfortumab Vedotin - Cohort 2	89

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	0	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	0	Not reported	Not reported	Not reported	Not reported

Glucose increased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	125
Enfortumab Vedotin - Cohort 2	89

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	NA	Not reported	Not reported	Not reported	Fasting glucose is required for CTCAE grading of hyperglycemia grade 1-2, not grade 3-4. Since fasting glucose was not required for this study, grade 1-2 (glucose-high) could not be determined. Only grade 3-4 was determined.
Enfortumab Vedotin - Cohort 2	NA	Not reported	Not reported	Not reported	Fasting glucose is required for CTCAE grading of hyperglycemia grade 1-2, not grade 3-4. Since fasting glucose was not required for this study, grade 1-2 (glucose-high) could not be determined. Only grade 3-4 was determined.

Glucose increased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	10	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	11	Not reported	Not reported	Not reported	Not reported

Phosphate decreased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	42	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	22	Not reported	Not reported	Not reported	Not reported

Phosphate decreased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	12	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	6	Not reported	Not reported	Not reported	Not reported

Potassium decreased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	25	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	11	Not reported	Not reported	Not reported	Not reported

Potassium decreased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	2	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	1	Not reported	Not reported	Not reported	Not reported

Potassium increased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	13	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	17	Not reported	Not reported	Not reported	Not reported

Potassium increased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	125
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	0	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	5	Not reported	Not reported	Not reported	Not reported

Sodium decreased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	54	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	28	Not reported	Not reported	Not reported	Not reported

Sodium decreased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	10	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	6	Not reported	Not reported	Not reported	Not reported

Sodium increased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	2	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	1	Not reported	Not reported	Not reported	Not reported

Sodium increased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	125
Enfortumab Vedotin - Cohort 2	89

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	0	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	0	Not reported	Not reported	Not reported	Not reported

Urate increased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	32	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	38	Not reported	Not reported	Not reported	Not reported

Urate increased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	8	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	8	Not reported	Not reported	Not reported	Not reported

Amylase increased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	20	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	18	Not reported	Not reported	Not reported	Not reported

Amylase increased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	1	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	3	Not reported	Not reported	Not reported	Not reported

Lipase increased (all grades)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	37	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	32	Not reported	Not reported	Not reported	Not reported

Lipase increased (grade 3-4)

Analysis denominator · Participants

Group	Source count
Enfortumab Vedotin - Cohort 1	122
Enfortumab Vedotin - Cohort 2	88

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin - Cohort 1	12	Not reported	Not reported	Not reported	Not reported
Enfortumab Vedotin - Cohort 2	10	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
34
group Id
OG001
value
26
denoms
counts
group Id
OG000
value
122
group Id
OG001
value
88
units
Participants
title
Alanine aminotransferase increased (all grades)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
122
group Id
OG001
value
89
units
Participants
title
Alanine aminotransferase increased (grade 3-4)
categories
measurements
group Id
OG000
value
38
group Id
OG001
value
16
denoms
counts
group Id
OG000
value
122
group Id
OG001
value
88
units
Participants
title
Albumin decreased (all grades)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
122
group Id
OG001
value
89
units
Participants
title
Albumin decreased (grade 3-4)
categories
measurements
group Id
OG000
value
21
group Id
OG001
value
12
denoms
counts
group Id
OG000
value
122
group Id
OG001
value
88
units
Participants
title
Alkaline phosphatase increased (all grades)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
122
group Id
OG001
value
88
units
Participants
title
Alkaline phosphatase increased (grade 3-4)
categories
measurements
group Id
OG000
value
79
group Id
OG001
value
52
denoms
counts
group Id
OG000
value
121
group Id
OG001
value
88
units
Participants
title
Aspartate aminotransferase increased (all grades)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
denoms
counts
group Id
OG000
value
121
group Id
OG001
value
88
units
Participants
title
Aspartate aminotransferase increased (grade 3-4)
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
5
denoms
counts
group Id
OG000
value
122
group Id
OG001
value
88
units
Participants
title
Bilirubin increased (all grades)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
122
group Id
OG001
value
89
units
Participants
title
Bilirubin increased (grade 3-4)
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
7
denoms
counts
group Id
OG000
value
122
group Id
OG001
value
88
units
Participants
title
Calcium decreased (all grades)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
125
group Id
OG001
value
89
units
Participants
title
Calcium decreased (grade 3-4)

denoms

counts
group Id
OG000
value
125
group Id
OG001
value
89
units
Participants

description

A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose. Abnormalities were graded based NCI CTCAE version 4.03 - Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.

groups

description
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
id
OG000
title
Enfortumab Vedotin - Cohort 1
description
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
id
OG001
title
Enfortumab Vedotin - Cohort 2

param Type

COUNT_OF_PARTICIPANTS

population Description

Safety Analysis set. Here 'Number Analyzed' for each laboratory parameter is based on the number of participants who received at least one dose of enfortumab vedotin and have a baseline and post-baseline laboratory value.

reporting Status

POSTED

time Frame

The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months]

title

Number of Participants With Treatment-Emergent Laboratory Abnormalities (Serum Chemistry)

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice