NCT03219333 · OUTCOME
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology)
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 [range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [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 on National Cancer Institute's Common Terminology Criteria for Adverse Events (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
Hemoglobin 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 | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 39 | Not reported | Not reported | Not reported | Not reported |
|---|
Hemoglobin 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 | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Leukocytes 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 | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
Leukocytes 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 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocytes 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 | 55 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 61 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocytes 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 | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocytes increased (all grades)
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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocytes 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 |
|---|
Neutrophils 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 | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
Neutrophils 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 | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Platelets decreased (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 | 39 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
Platelets 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 |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 39
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 88
- units
- Participants
- title
- Hemoglobin decreased (all grades)
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 88
- units
- Participants
- title
- Hemoglobin decreased (grade 3-4)
- categories
- measurements
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 28
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 88
- units
- Participants
- title
- Leukocytes decreased (all grades)
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 88
- units
- Participants
- title
- Leukocytes decreased (grade 3-4)
- categories
- measurements
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 61
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 88
- units
- Participants
- title
- Lymphocytes decreased (all grades)
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 13
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 88
- units
- Participants
- title
- Lymphocytes decreased (grade 3-4)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 125
- group Id
- OG001
- value
- 88
- units
- Participants
- title
- Lymphocytes increased (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
- Lymphocytes increased (grade 3-4)
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 27
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 88
- units
- Participants
- title
- Neutrophils decreased (all grades)
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 88
- units
- Participants
- title
- Neutrophils decreased (grade 3-4)
- categories
- measurements
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 20
- denoms
- counts
- group Id
- OG000
- value
- 121
- group Id
- OG001
- value
- 88
- units
- Participants
- title
- Platelets 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
- Platelets 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 on National Cancer Institute's Common Terminology Criteria for Adverse Events (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 [range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [range: 0.3, 24.6 months]
- title
- Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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