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A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

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ClinicalTrials.gov Identifier: NCT03474107
Recruitment Status : Active, not recruiting
First Posted : March 22, 2018
Results First Posted : August 24, 2021
Last Update Posted : September 20, 2021
Sponsor:
Collaborator:
Seagen Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ureteral Cancer
Urothelial Cancer
Bladder Cancer
Interventions Drug: Enfortumab Vedotin
Drug: Docetaxel
Drug: Vinflunine
Drug: Paclitaxel
Enrollment 608
Recruitment Details Adult participants with locally advanced or metastatic urothelial cancer (mUC) who had received a platinum-containing chemotherapy and had experienced disease progression or relapse during or following treatment with programmed cell death protein-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors.
Pre-assignment Details Participants were stratified by Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 vs 1), regions of the world Western EU vs US vs Rest of World) and liver metastasis (Yes vs No).
Arm/Group Title Enfortumab Vedotin 1.25mg/kg Chemotherapy
Hide Arm/Group Description Participants received 1.25 milligrams per kilogram (mg/kg) of body weight enfortumab vedotin by intravenous (IV) infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first. Participants received either 75 milligram per square meter (mg/m^2) docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Period Title: Overall Study
Started 301 307
Treated 296 291
Completed 56 [1] 22 [1]
Not Completed 245 285
Reason Not Completed
Adverse Event             42             46
Death             2             2
Lost to Follow-up             0             1
Progressive Disease             177             180
Protocol Violation             1             1
Withdrawal by Subject             15             27
Physician Decision             7             22
Miscellaneous             1             6
[1]
Participants still on treatment as of data cut-off date 15-Jul-2020
Arm/Group Title Enfortumab Vedotin 1.25 mg/kg Chemotherapy Total
Hide Arm/Group Description Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first. Participants received either 75 mg/m^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first. Total of all reporting groups
Overall Number of Baseline Participants 301 307 608
Hide Baseline Analysis Population Description
The full analysis set (FAS) consisted of all participants who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 301 participants 307 participants 608 participants
66.52  (9.11) 66.81  (9.93) 66.67  (9.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants 307 participants 608 participants
Female
63
  20.9%
75
  24.4%
138
  22.7%
Male
238
  79.1%
232
  75.6%
470
  77.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants 307 participants 608 participants
Hispanic or Latino
29
   9.6%
24
   7.8%
53
   8.7%
Not Hispanic or Latino
230
  76.4%
238
  77.5%
468
  77.0%
Unknown or Not Reported
42
  14.0%
45
  14.7%
87
  14.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants 307 participants 608 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
97
  32.2%
103
  33.6%
200
  32.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.3%
1
   0.2%
Black or African American
2
   0.7%
2
   0.7%
4
   0.7%
White
159
  52.8%
155
  50.5%
314
  51.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
43
  14.3%
46
  15.0%
89
  14.6%
ECOG PS   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants 307 participants 608 participants
ECOG PS=0 120 124 244
ECOG PS=1 181 183 364
[1]
Measure Description:

ECOG PS was measured on 6 point scale 0-Fully active, able to carry on all pre-disease performance without restriction

  1. Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature
  2. Ambulatory & capable of all self-care but unable to carry out any work activities.Up & about more than 50% of waking hours
  3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
  4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
  5. Dead Participants were categorized based on ECOG PS 0 or 1
Liver Metastasis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants 307 participants 608 participants
Liver Metastasis=No 208 212 420
Liver Metastasis=Yes 93 95 188
[1]
Measure Description: Participants were categorized based on liver metastasis (yes or no).
Region   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants 307 participants 608 participants
Western Europe 126 129 255
United States 43 44 87
Rest of the World 132 134 266
[1]
Measure Description: Participants were categorized based on region western europe, US and rest of the world.
1.Primary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from the date of randomization until the documented date of death from any cause. OS was analyzed using Kaplan-Meier estimates. Participants who were still alive at the time of data cutoff date were to be censored at the last known alive date or at the data cutoff date, whichever was earlier.
Time Frame From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population
Arm/Group Title Enfortumab Vedotin 1.25 mg/kg Chemotherapy
Hide Arm/Group Description:
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Participants received either 75 mg/m^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Overall Number of Participants Analyzed 301 307
Median (95% Confidence Interval)
Unit of Measure: months
12.88
(10.58 to 15.21)
8.97
(8.05 to 10.74)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enfortumab Vedotin 1.25 mg/kg, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00142
Comments Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P-value of overall survival is ≤ the predetermined 1-sided significance level of 0.00679 based on the number of observed deaths.
Method Stratified Log rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified Hazard Ratio
Estimated Value 0.702
Confidence Interval (2-Sided) 95%
0.556 to 0.886
Estimation Comments Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.
2.Secondary Outcome
Title Progression Free Survival on Study Therapy (PFS1) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Hide Description PFS: time from date of randomization until date of documented radiological disease progression (PD) per investigator based on RECIST V1.1, or until death due to any cause, whichever occurred first. PD: >= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of >= 5 mm. Appearance of 1 or more new lesions is also considered progression. A participant who neither progressed nor died was censored at date of last radiological assessment (RA)/ date of randomization if no post-baseline RA was available. Participants who received any further anticancer therapy (ACT) for disease before radiological progression was censored at date of last RA before ACT started and participants who had PD/death after >=2 missed RAs were censored at last RA prior to 2 or more missed RAs. Kaplan-Meier estimates was used. Median time of follow-up for PFS was based on data cut-off & is same as median follow-up time for OS.
Time Frame From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population
Arm/Group Title Enfortumab Vedotin 1.25 mg/kg Chemotherapy
Hide Arm/Group Description:
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Participants received either 75 mg/m^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Overall Number of Participants Analyzed 301 307
Median (95% Confidence Interval)
Unit of Measure: months
5.55
(5.32 to 5.82)
3.71
(3.52 to 3.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enfortumab Vedotin 1.25 mg/kg, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P value of PFS is ≤ the predetermined 1-sided significance level of 0.02189 based on the number of observed PFS events.
Method Stratified Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified Hazard Ratio
Estimated Value 0.615
Confidence Interval (2-Sided) 95%
0.505 to 0.748
Estimation Comments Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.
3.Secondary Outcome
Title Overall Response Rate (ORR) as Per RECIST V1.1
Hide Description ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) based on the RECIST v1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. ORR was analysed using exact method based on binomial distribution (Clopper-Pearson). Median time of follow up for ORR was based on data cut-off and is same as median follow-up time for OS.
Time Frame From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Response Evaluable Set (RES): The RES was defined as all participants in the FAS who had measurable disease (per RECIST v1.1) per investigator at baseline.
Arm/Group Title Enfortumab Vedotin 1.25 mg/kg Chemotherapy
Hide Arm/Group Description:
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Participants received either 75 mg/m^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Overall Number of Participants Analyzed 288 296
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40.6
(34.90 to 46.54)
17.9
(13.71 to 22.76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enfortumab Vedotin 1.25 mg/kg, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments "Stratification factors were ECOG PS, Region and Liver Metastasis.
Method Stratified Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Disease Control Rate (DCR) as Per RECIST V1.1
Hide Description DCR was defined as the percentage of participants with a CR, PR or a stable disease (SD) based on RECIST v1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug. Progressive disease is defined in PFS1 endpoint. DCR was analysed using exact method based on binomial distribution (Clopper-Pearson). Median time of follow up for DCR was based on data cut-off and is same as median follow-up time for OS.
Time Frame From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
RES Population
Arm/Group Title Enfortumab Vedotin 1.25 mg/kg Chemotherapy
Hide Arm/Group Description:
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Participants received either 75 mg/m^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Overall Number of Participants Analyzed 288 296
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
71.9
(66.30 to 76.99)
53.4
(47.52 to 59.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enfortumab Vedotin 1.25 mg/kg, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Stratification factors were ECOG PS, Region and Liver Metastasis.
Method Stratified Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Duration of Response (DOR) as Per RECIST V1.1
Hide Description DOR: time from the date of the first CR/PR (whichever is first recorded) that was subsequently confirmed as assessed by investigator to the date of documented PD or death due to any cause whichever occurred first. If a participant has neither progressed nor died, the participant was censored at the date of last RA or at the date of first CR/PR if no subsequent post-baseline RA was available. Participants who received any further ACT for the disease before radiological progression were censored at the date of the last RA before the ACT started. In addition, participants who had PD/death after >= 2 missed RAs were censored at the last RA prior to the 2 or more missed RAs. Kaplan-Meier estimates was used. Median time of follow up for DOR was based on data cut-off and is same as median follow-up time for OS. CR/PR and PD were defined in ORR and PFS1 endpoints, respectively.
Time Frame From date of first objective response until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
RES population with available data.
Arm/Group Title Enfortumab Vedotin 1.25 mg/kg Chemotherapy
Hide Arm/Group Description:
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Participants received either 75 mg/m^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Overall Number of Participants Analyzed 117 53
Median (95% Confidence Interval)
Unit of Measure: months
7.39
(5.59 to 9.46)
8.11
(5.65 to 9.56)
6.Secondary Outcome
Title Change From Baseline to Week 12 in European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Global Health Status (QL2 Score)
Hide Description EORTC QLQ-C30 is a generic questionnaire consisting of 30 items. The instrument yields functional scales (physical, role, emotional, cognitive, social), symptom scales/items (fatigue, Nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea), global health status, and financial impact score. Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the global health status/QoL, which are scored 1 ("very poor") to 7 ("excellent"). The recall period for each question is "during the past week". All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. Higher scores on the global health status and functioning scales indicate better health status/function.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with available data.
Arm/Group Title Enfortumab Vedotin 1.25 mg/kg Chemotherapy
Hide Arm/Group Description:
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Participants received either 75 mg/m^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Overall Number of Participants Analyzed 127 102
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.30  (18.02) -5.72  (16.04)
7.Secondary Outcome
Title Change From Baseline to Week 12 in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)
Hide Description EQ-5D-5L is a health status instrument for self-reported assessment of 5 domains of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain is rated by selecting 1 of 5 standardized categorizations ranging from no problem to extreme problem. The final question is a visual analogue scale (VAS) to rank health status from 0 (best health imaginable) to 100 (worst health imaginable).
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with available data.
Arm/Group Title Enfortumab Vedotin 1.25 mg/kg Chemotherapy
Hide Arm/Group Description:
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Participants received either 75 mg/m^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Overall Number of Participants Analyzed 124 102
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.8  (16.6) -5.3  (14.5)
8.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events
Hide Description An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE is defined as an AE observed or worsened after starting administration of the study drug.
Time Frame From first dose up to 30 days after last dose (Median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAF) consisted of all participants who received any amount of study drug, and was used for safety analyses.
Arm/Group Title Enfortumab Vedotin 1.25 mg/kg Chemotherapy
Hide Arm/Group Description:
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Participants received either 75 mg/m^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Overall Number of Participants Analyzed 296 291
Measure Type: Number
Unit of Measure: participants
290 288
9.Secondary Outcome
Title Number of Participants With ECOG Performance Status
Hide Description

ECOG performance status was measured on an 6 point scale. 0-Fully active, able to carry on all pre-disease performance without restriction.

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
  2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
  3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
  4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
  5. Dead. Number of participants with ECOG PS was reported.
Time Frame End of treatment (EOT) (Median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with available data.
Arm/Group Title Enfortumab Vedotin 1.25 mg/kg Chemotherapy
Hide Arm/Group Description:
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Participants received either 75 mg/m^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
Overall Number of Participants Analyzed 184 219
Measure Type: Number
Unit of Measure: participants
ECOG PS = 0 34 57
ECOG PS = 1 110 118
ECOG PS >1 40 44
Time Frame From first dose up to 30 days after last dose (Median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enfortumab Vedotin Chemotherapy
Hide Arm/Group Description Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first. Participants received either 75 mg/m^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
All-Cause Mortality
Enfortumab Vedotin Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   130/296 (43.92%)      161/291 (55.33%)    
Hide Serious Adverse Events
Enfortumab Vedotin Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   138/296 (46.62%)      128/291 (43.99%)    
Blood and lymphatic system disorders     
Anaemia * 1  4/296 (1.35%)  4 6/291 (2.06%)  7
Bone marrow failure * 1  0/296 (0.00%)  0 2/291 (0.69%)  4
Febrile neutropenia * 1  4/296 (1.35%)  4 16/291 (5.50%)  16
Leukopenia * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Neutropenia * 1  4/296 (1.35%)  4 8/291 (2.75%)  9
Pancytopenia * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Thrombocytopenia * 1  2/296 (0.68%)  2 0/291 (0.00%)  0
Cardiac disorders     
Angina pectoris * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Atrial fibrillation * 1  5/296 (1.69%)  5 1/291 (0.34%)  1
Atrial flutter * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Bradycardia * 1  1/296 (0.34%)  1 1/291 (0.34%)  1
Cardiac arrest * 1  0/296 (0.00%)  0 2/291 (0.69%)  2
Cardiac failure * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Cardiogenic shock * 1  0/296 (0.00%)  0 1/291 (0.34%)  2
Myocardial infarction * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Palpitations * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Sinus tachycardia * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Ventricular hypokinesia * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Ear and labyrinth disorders     
Deafness neurosensory * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Vertigo * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Endocrine disorders     
Adrenal insufficiency * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Inappropriate antidiuretic hormone secretion * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Eye disorders     
Blepharitis * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Cataract * 1  2/296 (0.68%)  5 0/291 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain * 1  3/296 (1.01%)  3 6/291 (2.06%)  6
Abdominal pain lower * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Abdominal pain upper * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Ascites * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Colitis * 1  1/296 (0.34%)  1 1/291 (0.34%)  1
Colonic fistula * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Constipation * 1  2/296 (0.68%)  2 3/291 (1.03%)  3
Diarrhoea * 1  7/296 (2.36%)  8 4/291 (1.37%)  6
Duodenal obstruction * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Fistula of small intestine * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Gastrointestinal haemorrhage * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Haemorrhagic ascites * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Ileus * 1  1/296 (0.34%)  1 2/291 (0.69%)  2
Intestinal obstruction * 1  0/296 (0.00%)  0 2/291 (0.69%)  3
Nausea * 1  2/296 (0.68%)  2 2/291 (0.69%)  2
Oesophagitis * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Rectal haemorrhage * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Small intestinal obstruction * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Upper gastrointestinal haemorrhage * 1  0/296 (0.00%)  0 2/291 (0.69%)  2
Vomiting * 1  5/296 (1.69%)  5 1/291 (0.34%)  1
General disorders     
Asthenia * 1  3/296 (1.01%)  3 1/291 (0.34%)  1
Chest pain * 1  1/296 (0.34%)  1 1/291 (0.34%)  1
Chills * 1  2/296 (0.68%)  2 1/291 (0.34%)  1
Death * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Extravasation * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Fatigue * 1  3/296 (1.01%)  4 2/291 (0.69%)  2
General physical health deterioration * 1  2/296 (0.68%)  3 5/291 (1.72%)  5
Malaise * 1  2/296 (0.68%)  2 3/291 (1.03%)  4
Mucosal inflammation * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Multiple organ dysfunction syndrome * 1  3/296 (1.01%)  3 0/291 (0.00%)  0
Non-cardiac chest pain * 1  1/296 (0.34%)  1 1/291 (0.34%)  1
Oedema peripheral * 1  2/296 (0.68%)  2 1/291 (0.34%)  1
Pyrexia * 1  6/296 (2.03%)  6 9/291 (3.09%)  11
Systemic inflammatory response syndrome * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Hepatobiliary disorders     
Cholangitis * 1  1/296 (0.34%)  2 0/291 (0.00%)  0
Cholecystitis acute * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Hepatic function abnormal * 1  2/296 (0.68%)  4 1/291 (0.34%)  2
Liver disorder * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Immune system disorders     
Hypersensitivity * 1  2/296 (0.68%)  2 0/291 (0.00%)  0
Infections and infestations     
Abscess bacterial * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Appendicitis * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Bacteraemia * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Bronchitis * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Cellulitis * 1  3/296 (1.01%)  3 2/291 (0.69%)  4
Clostridium difficile colitis * 1  0/296 (0.00%)  0 1/291 (0.34%)  2
Conjunctivitis * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Device related infection * 1  1/296 (0.34%)  1 1/291 (0.34%)  1
Device related sepsis * 1  1/296 (0.34%)  2 0/291 (0.00%)  0
Escherichia pyelonephritis * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Escherichia urinary tract infection * 1  3/296 (1.01%)  4 1/291 (0.34%)  1
Febrile infection * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Gastroenteritis * 1  0/296 (0.00%)  0 1/291 (0.34%)  2
Infected skin ulcer * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Infection * 1  2/296 (0.68%)  2 0/291 (0.00%)  0
Infective spondylitis * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Neutropenic sepsis * 1  0/296 (0.00%)  0 1/291 (0.34%)  2
Pelvic abscess * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Pleural infection * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Pneumocystis jirovecii pneumonia * 1  0/296 (0.00%)  0 2/291 (0.69%)  5
Pneumonia * 1  12/296 (4.05%)  14 7/291 (2.41%)  9
Pneumonia klebsiella * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Pneumonia legionella * 1  0/296 (0.00%)  0 1/291 (0.34%)  3
Pneumonia pneumococcal * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Pneumonia viral * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Pyelonephritis * 1  0/296 (0.00%)  0 2/291 (0.69%)  5
Pyelonephritis acute * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Sepsis * 1  5/296 (1.69%)  6 3/291 (1.03%)  5
Septic shock * 1  4/296 (1.35%)  6 1/291 (0.34%)  2
Staphylococcal bacteraemia * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Staphylococcal sepsis * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Streptococcal urinary tract infection * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Urinary tract infection * 1  7/296 (2.36%)  7 6/291 (2.06%)  7
Urinary tract infection bacterial * 1  9/296 (3.04%)  10 3/291 (1.03%)  3
Urinary tract infection enterococcal * 1  1/296 (0.34%)  1 1/291 (0.34%)  1
Urosepsis * 1  2/296 (0.68%)  2 6/291 (2.06%)  7
Injury, poisoning and procedural complications     
Ankle fracture * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Fall * 1  2/296 (0.68%)  2 1/291 (0.34%)  1
Infusion related reaction * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Radius fracture * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Reactive gastropathy * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Toxicity to various agents * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Investigations     
Blood creatinine increased * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
C-reactive protein increased * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Gamma-glutamyltransferase increased * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Hepatic enzyme increased * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Neutrophil count decreased * 1  2/296 (0.68%)  3 5/291 (1.72%)  6
Platelet count decreased * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Metabolism and nutrition disorders     
Decreased appetite * 1  5/296 (1.69%)  5 1/291 (0.34%)  1
Dehydration * 1  2/296 (0.68%)  2 4/291 (1.37%)  4
Hypercalcaemia * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Hyperglycaemia * 1  4/296 (1.35%)  5 1/291 (0.34%)  1
Hyperkalaemia * 1  1/296 (0.34%)  1 4/291 (1.37%)  4
Hypernatraemia * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Hypoglycaemia * 1  1/296 (0.34%)  1 2/291 (0.69%)  2
Hyponatraemia * 1  2/296 (0.68%)  2 3/291 (1.03%)  3
Hypophagia * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Hypovolaemia * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Metabolic acidosis * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Type 2 diabetes mellitus * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain * 1  2/296 (0.68%)  2 3/291 (1.03%)  3
Bone pain * 1  1/296 (0.34%)  1 1/291 (0.34%)  1
Lumbar spinal stenosis * 1  1/296 (0.34%)  2 0/291 (0.00%)  0
Muscular weakness * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Myalgia * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Pain in extremity * 1  1/296 (0.34%)  1 1/291 (0.34%)  1
Pathological fracture * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma gastric * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Bladder transitional cell carcinoma * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Malignant neoplasm progression * 1  12/296 (4.05%)  15 7/291 (2.41%)  7
Malignant pleural effusion * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Metastases to central nervous system * 1  1/296 (0.34%)  1 1/291 (0.34%)  1
Tumour associated fever * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Tumour haemorrhage * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Nervous system disorders     
Brain oedema * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Cerebral haematoma * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Dementia * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Encephalopathy * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Frontotemporal dementia * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Neuralgia * 1  1/296 (0.34%)  1 1/291 (0.34%)  1
Peripheral sensorimotor neuropathy * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Peripheral sensory neuropathy * 1  2/296 (0.68%)  2 1/291 (0.34%)  1
Polyneuropathy * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Spinal cord compression * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Syncope * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Product Issues     
Device occlusion * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Psychiatric disorders     
Confusional state * 1  2/296 (0.68%)  2 2/291 (0.69%)  2
Delirium * 1  1/296 (0.34%)  1 3/291 (1.03%)  3
Renal and urinary disorders     
Acute kidney injury * 1  19/296 (6.42%)  31 7/291 (2.41%)  7
Azotaemia * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Calculus bladder * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Choluria * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Cystitis noninfective * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Haematuria * 1  5/296 (1.69%)  6 3/291 (1.03%)  3
Hydronephrosis * 1  3/296 (1.01%)  3 1/291 (0.34%)  1
Renal impairment * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Urinary retention * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Urinary tract obstruction * 1  1/296 (0.34%)  1 1/291 (0.34%)  1
Reproductive system and breast disorders     
Metrorrhagia * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Aspiration * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Cough * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Dyspnoea * 1  4/296 (1.35%)  5 3/291 (1.03%)  3
Hiccups * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Interstitial lung disease * 1  0/296 (0.00%)  0 2/291 (0.69%)  2
Laryngospasm * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Organising pneumonia * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Pleural effusion * 1  2/296 (0.68%)  2 1/291 (0.34%)  1
Pneumonitis * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Pulmonary embolism * 1  2/296 (0.68%)  2 0/291 (0.00%)  0
Respiratory distress * 1  0/296 (0.00%)  0 1/291 (0.34%)  2
Respiratory failure * 1  1/296 (0.34%)  2 1/291 (0.34%)  1
Skin and subcutaneous tissue disorders     
Blister * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Decubitus ulcer * 1  1/296 (0.34%)  1 1/291 (0.34%)  1
Dermatitis bullous * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Drug eruption * 1  2/296 (0.68%)  5 0/291 (0.00%)  0
Rash * 1  3/296 (1.01%)  3 0/291 (0.00%)  0
Rash maculo-papular * 1  4/296 (1.35%)  4 0/291 (0.00%)  0
Rash vesicular * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Toxic skin eruption * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Vascular disorders     
Aortic aneurysm * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Deep vein thrombosis * 1  0/296 (0.00%)  0 2/291 (0.69%)  2
Hypotension * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
Iliac artery occlusion * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Vascular compression * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Vein disorder * 1  0/296 (0.00%)  0 1/291 (0.34%)  1
Vena cava thrombosis * 1  1/296 (0.34%)  1 0/291 (0.00%)  0
1
Term from vocabulary, MedDRA v23.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enfortumab Vedotin Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   284/296 (95.95%)      266/291 (91.41%)    
Blood and lymphatic system disorders     
Anaemia * 1  57/296 (19.26%)  98 83/291 (28.52%)  136
Neutropenia * 1  16/296 (5.41%)  30 20/291 (6.87%)  37
Eye disorders     
Dry eye * 1  19/296 (6.42%)  24 3/291 (1.03%)  3
Lacrimation increased * 1  30/296 (10.14%)  37 12/291 (4.12%)  15
Vision blurred * 1  16/296 (5.41%)  20 5/291 (1.72%)  5
Gastrointestinal disorders     
Abdominal pain * 1  37/296 (12.50%)  52 24/291 (8.25%)  33
Constipation * 1  81/296 (27.36%)  116 72/291 (24.74%)  105
Diarrhoea * 1  98/296 (33.11%)  171 64/291 (21.99%)  89
Dry mouth * 1  24/296 (8.11%)  26 7/291 (2.41%)  7
Dyspepsia * 1  19/296 (6.42%)  22 9/291 (3.09%)  10
Nausea * 1  89/296 (30.07%)  119 73/291 (25.09%)  92
Stomatitis * 1  27/296 (9.12%)  35 19/291 (6.53%)  27
Vomiting * 1  38/296 (12.84%)  50 44/291 (15.12%)  57
General disorders     
Asthenia * 1  43/296 (14.53%)  85 39/291 (13.40%)  85
Chills * 1  16/296 (5.41%)  18 5/291 (1.72%)  5
Fatigue * 1  107/296 (36.15%)  197 77/291 (26.46%)  121
Malaise * 1  12/296 (4.05%)  13 19/291 (6.53%)  24
Oedema peripheral * 1  25/296 (8.45%)  32 39/291 (13.40%)  46
Pyrexia * 1  60/296 (20.27%)  99 33/291 (11.34%)  47
Infections and infestations     
Conjunctivitis * 1  18/296 (6.08%)  23 2/291 (0.69%)  2
Nasopharyngitis * 1  15/296 (5.07%)  18 9/291 (3.09%)  9
Urinary tract infection * 1  21/296 (7.09%)  22 12/291 (4.12%)  15
Injury, poisoning and procedural complications     
Fall * 1  15/296 (5.07%)  19 8/291 (2.75%)  8
Investigations     
Alanine aminotransferase increased * 1  27/296 (9.12%)  45 4/291 (1.37%)  5
Aspartate aminotransferase increased * 1  36/296 (12.16%)  56 5/291 (1.72%)  7
Blood creatinine increased * 1  26/296 (8.78%)  38 6/291 (2.06%)  6
Lymphocyte count decreased * 1  12/296 (4.05%)  35 17/291 (5.84%)  50
Neutrophil count decreased * 1  32/296 (10.81%)  70 52/291 (17.87%)  159
Weight decreased * 1  47/296 (15.88%)  73 20/291 (6.87%)  20
White blood cell count decreased * 1  16/296 (5.41%)  45 32/291 (11.00%)  97
Metabolism and nutrition disorders     
Decreased appetite * 1  119/296 (40.20%)  157 78/291 (26.80%)  104
Hyperglycaemia * 1  28/296 (9.46%)  64 5/291 (1.72%)  7
Hypokalaemia * 1  19/296 (6.42%)  22 10/291 (3.44%)  22
Hypomagnesaemia * 1  18/296 (6.08%)  28 8/291 (2.75%)  9
Hyponatraemia * 1  19/296 (6.42%)  36 10/291 (3.44%)  13
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  19/296 (6.42%)  23 36/291 (12.37%)  44
Back pain * 1  25/296 (8.45%)  28 23/291 (7.90%)  25
Muscular weakness * 1  15/296 (5.07%)  23 7/291 (2.41%)  8
Myalgia * 1  15/296 (5.07%)  23 31/291 (10.65%)  40
Pain in extremity * 1  16/296 (5.41%)  20 13/291 (4.47%)  19
Nervous system disorders     
Dizziness * 1  26/296 (8.78%)  34 16/291 (5.50%)  18
Dysgeusia * 1  74/296 (25.00%)  99 23/291 (7.90%)  28
Headache * 1  9/296 (3.04%)  10 17/291 (5.84%)  22
Neuropathy peripheral * 1  20/296 (6.76%)  45 16/291 (5.50%)  20
Paraesthesia * 1  15/296 (5.07%)  23 8/291 (2.75%)  10
Peripheral sensory neuropathy * 1  102/296 (34.46%)  301 66/291 (22.68%)  99
Psychiatric disorders     
Insomnia * 1  31/296 (10.47%)  32 23/291 (7.90%)  25
Renal and urinary disorders     
Haematuria * 1  31/296 (10.47%)  41 22/291 (7.56%)  28
Respiratory, thoracic and mediastinal disorders     
Cough * 1  24/296 (8.11%)  25 17/291 (5.84%)  17
Dyspnoea * 1  25/296 (8.45%)  31 26/291 (8.93%)  36
Skin and subcutaneous tissue disorders     
Alopecia * 1  139/296 (46.96%)  163 110/291 (37.80%)  121
Drug eruption * 1  26/296 (8.78%)  40 4/291 (1.37%)  4
Dry skin * 1  50/296 (16.89%)  57 11/291 (3.78%)  11
Pruritus * 1  102/296 (34.46%)  153 20/291 (6.87%)  20
Rash * 1  49/296 (16.55%)  77 16/291 (5.50%)  16
Rash maculo-papular * 1  49/296 (16.55%)  99 6/291 (2.06%)  6
Skin hyperpigmentation * 1  19/296 (6.42%)  20 1/291 (0.34%)  2
1
Term from vocabulary, MedDRA v23.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure
Organization: Astellas Pharma Global Development, Inc.
Phone: 800-888-7704
EMail: astellas.resultsdisclosure@astellas.com
Layout table for additonal information
Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT03474107    
Other Study ID Numbers: 7465-CL-0301
2017-003344-21 ( EudraCT Number )
First Submitted: March 16, 2018
First Posted: March 22, 2018
Results First Submitted: July 7, 2021
Results First Posted: August 24, 2021
Last Update Posted: September 20, 2021