NCT03219333 · OUTCOME
Incidence of Antitherapeutic Antibody (ATA)
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
Participants who were tested positive for ATA at any time post-baseline were considered to be transiently positive or persistently positive if \>=2 consecutive samples were confirmed as positive.
Analysis population: Safety Analysis Set: Participants who received at least one dose of enfortumab vedotin. Here, 'Overall Number of Participants Analyzed' signifies ATA subset (participants with a baseline and at least one post-baseline sample). Here, 'Number Analyzed' signifies participants evaluable for specified rows.
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 | 114 |
|---|
| Enfortumab Vedotin - Cohort 2 | 81 |
|---|
Reported measurements
Baseline Negative
Analysis denominator · Participants
| Group | Source count |
|---|
| Enfortumab Vedotin - Cohort 1 | 112 |
|---|
| Enfortumab Vedotin - Cohort 2 | 80 |
|---|
Negative post-baseline
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enfortumab Vedotin - Cohort 1 | 109 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 76 | Not reported | Not reported | Not reported | Not reported |
|---|
Transiently positive post-baseline
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 |
|---|
Persistently positive post-baseline
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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline Positive
Analysis denominator · Participants
| Group | Source count |
|---|
| Enfortumab Vedotin - Cohort 1 | 2 |
|---|
| Enfortumab Vedotin - Cohort 2 | 1 |
|---|
Negative post-baseline
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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Transiently positive post-baseline
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 |
|---|
Persistently positive post-baseline
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
- 109
- group Id
- OG001
- value
- 76
- title
- Negative post-baseline
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- title
- Transiently positive post-baseline
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- Persistently positive post-baseline
- denoms
- counts
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 80
- units
- Participants
- title
- Baseline Negative
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- Negative post-baseline
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Transiently positive post-baseline
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Persistently positive post-baseline
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Baseline Positive
- denoms
- counts
- group Id
- OG000
- value
- 114
- group Id
- OG001
- value
- 81
- units
- Participants
- description
- Participants who were tested positive for ATA at any time post-baseline were considered to be transiently positive or persistently positive if \>=2 consecutive samples were confirmed as positive.
- 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: Participants who received at least one dose of enfortumab vedotin. Here, 'Overall Number of Participants Analyzed' signifies ATA subset (participants with a baseline and at least one post-baseline sample). Here, 'Number Analyzed' signifies participants evaluable for specified rows.
- 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
- Incidence of Antitherapeutic Antibody (ATA)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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