NCT03219333 · OUTCOME
Number of Participants With Adverse Events (AEs): Primary Analysis
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
AE=untoward medical occurrence associated with use of study intervention, whether or not considered related. Treatment emergent adverse event (TEAE)=newly occurring/worsening AE after first dose of study treatment, within 30 days after last dose. According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03: Grade(G)3=severe AE, G4=life-threatening, urgent intervention indicated, G5=death related to AE. Participants who discontinued treatment due to treatment related TEAEs captured under TEAEs leading to treatment discontinuation. SAE=event at any dose led to death;life-threatening;required inpatient hospitalization/prolongation of existing hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect/ important medical event. Treatment related AEs, SAEs, deaths also included. Treatment relatedness was judged by investigator.
Analysis population: Safety Analysis Set: includes all participants who received at least one dose of enfortumab vedotin.
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
Any treatment-emergent AEs (TEAEs)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enfortumab Vedotin - Cohort 1 | 125 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 89 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-related TEAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enfortumab Vedotin - Cohort 1 | 117 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 86 | Not reported | Not reported | Not reported | Not reported |
|---|
Any grade 3-5 TEAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enfortumab Vedotin - Cohort 1 | 93 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 62 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-related grade 3-5 TEAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enfortumab Vedotin - Cohort 1 | 70 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 49 | Not reported | Not reported | Not reported | Not reported |
|---|
Any serious TEAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enfortumab Vedotin - Cohort 1 | 59 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-related serious TEAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Enfortumab Vedotin - Cohort 1 | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| Enfortumab Vedotin - Cohort 2 | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TEAEs leading to treatment discontinuation
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 | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-related TEAEs leading to treatment discontinuation
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 | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TEAEs leading to death
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 |
|---|
Treatment-related TEAEs leading to death
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 |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 125
- group Id
- OG001
- value
- 89
- title
- Any treatment-emergent AEs (TEAEs)
- categories
- measurements
- group Id
- OG000
- value
- 117
- group Id
- OG001
- value
- 86
- title
- Treatment-related TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 93
- group Id
- OG001
- value
- 62
- title
- Any grade 3-5 TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 70
- group Id
- OG001
- value
- 49
- title
- Treatment-related grade 3-5 TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 35
- title
- Any serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 15
- title
- Treatment-related serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 18
- title
- Any TEAEs leading to treatment discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 14
- title
- Treatment-related TEAEs leading to treatment discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 8
- title
- Any TEAEs leading to death
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- title
- Treatment-related TEAEs leading to death
- denoms
- counts
- group Id
- OG000
- value
- 125
- group Id
- OG001
- value
- 89
- units
- Participants
- description
- AE=untoward medical occurrence associated with use of study intervention, whether or not considered related. Treatment emergent adverse event (TEAE)=newly occurring/worsening AE after first dose of study treatment, within 30 days after last dose. According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03: Grade(G)3=severe AE, G4=life-threatening, urgent intervention indicated, G5=death related to AE. Participants who discontinued treatment due to treatment related TEAEs captured under TEAEs leading to treatment discontinuation. SAE=event at any dose led to death;life-threatening;required inpatient hospitalization/prolongation of existing hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect/ important medical event. Treatment related AEs, SAEs, deaths also included. Treatment relatedness was judged by investigator.
- 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: includes all participants who received at least one dose of enfortumab vedotin.
- 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 Adverse Events (AEs): Primary Analysis
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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