NCT03219333 · OUTCOME
PK Parameter for Enfortumab Vedotin: Time to Maximum Concentration (Tmax) (Serum)
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
- MEDIAN
- Unit
- Days
- Interval / dispersion
- Full Range
- Time frame
- Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22
What was measured
Tmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
Analysis population: PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Number Analyzed'= participants evaluable at specified timepoints.
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 | 120 |
|---|
| Enfortumab Vedotin - Cohort 2 | 87 |
|---|
Reported measurements
Cycle 1, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Enfortumab Vedotin - Cohort 1 | 119 |
|---|
| Enfortumab Vedotin - Cohort 2 | 87 |
|---|
Values in Days · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enfortumab Vedotin - Cohort 1 | 0.0278 | Not reported | 0.010 | 0.052 | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 0.0264 | Not reported | 0.021 | 0.088 | Not reported |
|---|
Cycle 1, Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Enfortumab Vedotin - Cohort 1 | 92 |
|---|
| Enfortumab Vedotin - Cohort 2 | 63 |
|---|
Values in Days · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enfortumab Vedotin - Cohort 1 | 0.0285 | Not reported | 0.014 | 0.054 | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 0.0264 | Not reported | 0.014 | 0.084 | Not reported |
|---|
Cycle 2, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Enfortumab Vedotin - Cohort 1 | 104 |
|---|
| Enfortumab Vedotin - Cohort 2 | 73 |
|---|
Values in Days · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enfortumab Vedotin - Cohort 1 | 0.0264 | Not reported | 0.011 | 0.042 | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 0.0264 | Not reported | 0.015 | 0.074 | Not reported |
|---|
Cycle 2, Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Enfortumab Vedotin - Cohort 1 | 94 |
|---|
| Enfortumab Vedotin - Cohort 2 | 62 |
|---|
Values in Days · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enfortumab Vedotin - Cohort 1 | 0.0285 | Not reported | 0.020 | 0.115 | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 0.0257 | Not reported | 0.010 | 0.047 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.010
- upper Limit
- 0.052
- value
- 0.0278
- group Id
- OG001
- lower Limit
- 0.021
- upper Limit
- 0.088
- value
- 0.0264
- denoms
- counts
- group Id
- OG000
- value
- 119
- group Id
- OG001
- value
- 87
- units
- Participants
- title
- Cycle 1, Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.014
- upper Limit
- 0.054
- value
- 0.0285
- group Id
- OG001
- lower Limit
- 0.014
- upper Limit
- 0.084
- value
- 0.0264
- denoms
- counts
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 63
- units
- Participants
- title
- Cycle 1, Day 15
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.011
- upper Limit
- 0.042
- value
- 0.0264
- group Id
- OG001
- lower Limit
- 0.015
- upper Limit
- 0.074
- value
- 0.0264
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 73
- units
- Participants
- title
- Cycle 2, Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.020
- upper Limit
- 0.115
- value
- 0.0285
- group Id
- OG001
- lower Limit
- 0.010
- upper Limit
- 0.047
- value
- 0.0257
- denoms
- counts
- group Id
- OG000
- value
- 94
- group Id
- OG001
- value
- 62
- units
- Participants
- title
- Cycle 2, Day 15
- denoms
- counts
- group Id
- OG000
- value
- 120
- group Id
- OG001
- value
- 87
- units
- Participants
- description
- Tmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Number Analyzed'= participants evaluable at specified timepoints.
- reporting Status
- POSTED
- time Frame
- Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22
- title
- PK Parameter for Enfortumab Vedotin: Time to Maximum Concentration (Tmax) (Serum)
- type
- SECONDARY
- unit Of Measure
- Days
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