NCT03219333 · OUTCOME
PK Parameter for TAb: 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. Time of maximum concentration corresponds to the end of infusion sample time. 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 | 74 |
|---|
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
- 74
- 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. Time of maximum concentration corresponds to the end of infusion sample time. 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 TAb: Tmax (Serum)
- type
- SECONDARY
- unit Of Measure
- Days
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Preserved source evidence · Not medical advice
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