Trial Outcomes & Findings for A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) (NCT NCT04172675)
NCT ID: NCT04172675
Last Updated: 2025-08-01
Results Overview
RFS was defined as the time from the date of randomization until the date of the reappearance of high-risk disease (high-grade Ta, T1 or carcinoma in situ \[CIS\]), or death, whichever was reported first. Recurrence was assessed using cystoscopy, bladder mapping, urine cytology, and computed tomography (CT)/ magnetic resonance imaging (MRI) urogram. Participants who were recurrence-free and alive or had unknown status were censored at the last tumor assessment. The Kaplan-Meier method was used to estimate the distribution of overall RFS for each treatment group.
COMPLETED
PHASE2
107 participants
From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months
2025-08-01
Participant Flow
Results are presented till final database lock date of 07 August 2024. Cohort 2 and Cohort 3 participants were involved in exploratory efficacy endpoints analysis and thus no efficacy data were reported in outcome measures section for Cohort 2 and 3. With implementation of Protocol Amendment 6 (dated 13 July 2023), long term extension (LTE) phase was added in study.
Participant milestones
| Measure |
Cohort 1: Erdafitinib
Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ \[CIS\], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 milligrams (mg) once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 1: Investigator's Choice
Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy and who either refused or were not eligible for cystectomy received the investigator's choice of treatment: either gemcitabine intravesical instillation (4 induction doses: 2000 mg once weekly on Days 1, 8, 15 and 22 of Cycle 1 followed by monthly maintenance dose on Day 1 of Cycle 2 to 7, each cycle of 28 days) or either mitomycin C (MMC) or hyperthermic MMC as an intravesical instillation at the dose of 40 mg/40 milliliter (mL). Additional doses of induction or maintenance were allowed per local standard of care. The choice of drug was determined by the investigator and treatment continued until its completion, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). Participants with locally confirmed high-risk recurrence on Investigator's Choice were offered an option to crossover treatment with erdafitinib until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 2: Erdafitinib
Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 3: Erdafitinib
Participants with intermediate-risk NMIBC presenting as papillary disease only (low grade \[Grade 1- Grade 2\], Ta or T1, with no previous CIS) received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
24
|
16
|
18
|
|
Overall Study
Participants of Cohort 1: Investigator's Choice Crossed Over to Cohort 1 Erdafitinib
|
0
|
9
|
0
|
0
|
|
Overall Study
Treated
|
49
|
23
|
16
|
18
|
|
Overall Study
COMPLETED
|
42
|
19
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
1
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1: Erdafitinib
Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ \[CIS\], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 milligrams (mg) once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 1: Investigator's Choice
Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy and who either refused or were not eligible for cystectomy received the investigator's choice of treatment: either gemcitabine intravesical instillation (4 induction doses: 2000 mg once weekly on Days 1, 8, 15 and 22 of Cycle 1 followed by monthly maintenance dose on Day 1 of Cycle 2 to 7, each cycle of 28 days) or either mitomycin C (MMC) or hyperthermic MMC as an intravesical instillation at the dose of 40 mg/40 milliliter (mL). Additional doses of induction or maintenance were allowed per local standard of care. The choice of drug was determined by the investigator and treatment continued until its completion, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). Participants with locally confirmed high-risk recurrence on Investigator's Choice were offered an option to crossover treatment with erdafitinib until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 2: Erdafitinib
Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 3: Erdafitinib
Participants with intermediate-risk NMIBC presenting as papillary disease only (low grade \[Grade 1- Grade 2\], Ta or T1, with no previous CIS) received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
1
|
4
|
Baseline Characteristics
A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
Baseline characteristics by cohort
| Measure |
Cohort 1: Erdafitinib
n=49 Participants
Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ \[CIS\], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 milligrams (mg) once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 1: Investigator's Choice
n=24 Participants
Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy and who either refused or were not eligible for cystectomy received the investigator's choice of treatment: either gemcitabine intravesical instillation (4 induction doses: 2000 mg once weekly on Days 1, 8, 15 and 22 of Cycle 1 followed by monthly maintenance dose on Day 1 of Cycle 2 to 7, each cycle of 28 days) or either mitomycin C (MMC) or hyperthermic MMC as an intravesical instillation at the dose of 40 mg/40 milliliter (mL). Additional doses of induction or maintenance were allowed per local standard of care. The choice of drug was determined by the investigator and treatment continued until its completion, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). Participants with locally confirmed high-risk recurrence on Investigator's Choice were offered an option to crossover treatment with erdafitinib until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 2: Erdafitinib
n=16 Participants
Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 3: Erdafitinib
n=18 Participants
Participants with intermediate-risk NMIBC presenting as papillary disease only (low grade \[Grade 1- Grade 2\], Ta or T1, with no previous CIS) received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.3 Years
STANDARD_DEVIATION 10.89 • n=5 Participants
|
67 Years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
66.7 Years
STANDARD_DEVIATION 12.37 • n=5 Participants
|
61.6 Years
STANDARD_DEVIATION 9.05 • n=4 Participants
|
66.6 Years
STANDARD_DEVIATION 11.04 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Region of Enrollment
Argentina
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
Brazil
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
China
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
India
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
Korea, South
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 monthsPopulation: Intent-to-Treat (ITT) analysis set included all randomized participants. Participants in Cohort 1 were primarily analyzed by the treatment to which they were assigned, regardless of the actual treatment received. Data for this outcome measure was planned to be collected and analyzed for specified arms only as planned in protocol.
RFS was defined as the time from the date of randomization until the date of the reappearance of high-risk disease (high-grade Ta, T1 or carcinoma in situ \[CIS\]), or death, whichever was reported first. Recurrence was assessed using cystoscopy, bladder mapping, urine cytology, and computed tomography (CT)/ magnetic resonance imaging (MRI) urogram. Participants who were recurrence-free and alive or had unknown status were censored at the last tumor assessment. The Kaplan-Meier method was used to estimate the distribution of overall RFS for each treatment group.
Outcome measures
| Measure |
Cohort 1: Erdafitinib
n=49 Participants
Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ \[CIS\], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 milligrams (mg) once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 1: Investigator's Choice
n=24 Participants
Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy and who either refused or were not eligible for cystectomy received the investigator's choice of treatment: either gemcitabine intravesical instillation (4 induction doses: 2000 mg once weekly on Days 1, 8, 15 and 22 of Cycle 1 followed by monthly maintenance dose on Day 1 of Cycle 2 to 7, each cycle of 28 days) or either mitomycin C (MMC) or hyperthermic MMC as an intravesical instillation at the dose of 40 mg/40 milliliter (mL). Additional doses of induction or maintenance were allowed per local standard of care. The choice of drug was determined by the investigator and treatment continued until its completion, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). Participants with locally confirmed high-risk recurrence on Investigator's Choice were offered an option to crossover treatment with erdafitinib until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 2: Erdafitinib
Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 3: Erdafitinib
Participants with intermediate-risk NMIBC presenting as papillary disease only (low grade \[Grade 1- Grade 2\], Ta or T1, with no previous CIS) received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
|---|---|---|---|---|
|
Cohort 1: Recurrence-Free Survival (RFS)
|
NA Months
Interval 28.58 to
Here, 'NA' signifies that median and upper limit of 95 percent (%) confidence interval (CI) could not be calculated due to less number of participants with event.
|
11.60 Months
Interval 5.29 to
Here, 'NA' signifies that upper limit of 95% CI could not be calculated due to less number of participants with event.
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12Population: ITT analysis set included all randomized participants. Participants in Cohort 1 were primarily analyzed by the treatment to which they were assigned, regardless of the actual treatment received. Data for this outcome measure was planned to be collected and analyzed for specified arms only as planned in protocol.
RFS rate was the proportion of participants who were recurrence-free and alive based on Kaplan-Meier estimates. RFS was defined as the time from the date of randomization until the date of the reappearance of high-risk disease (high-grade Ta, T1 or CIS), or death, whichever was reported first. Recurrence was assessed using cystoscopy, bladder mapping, urine cytology, and CT/ MRI urogram. Participants who were recurrence-free and alive or had unknown status were censored at the last tumor assessment.
Outcome measures
| Measure |
Cohort 1: Erdafitinib
n=49 Participants
Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ \[CIS\], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 milligrams (mg) once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 1: Investigator's Choice
n=24 Participants
Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy and who either refused or were not eligible for cystectomy received the investigator's choice of treatment: either gemcitabine intravesical instillation (4 induction doses: 2000 mg once weekly on Days 1, 8, 15 and 22 of Cycle 1 followed by monthly maintenance dose on Day 1 of Cycle 2 to 7, each cycle of 28 days) or either mitomycin C (MMC) or hyperthermic MMC as an intravesical instillation at the dose of 40 mg/40 milliliter (mL). Additional doses of induction or maintenance were allowed per local standard of care. The choice of drug was determined by the investigator and treatment continued until its completion, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). Participants with locally confirmed high-risk recurrence on Investigator's Choice were offered an option to crossover treatment with erdafitinib until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 2: Erdafitinib
Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 3: Erdafitinib
Participants with intermediate-risk NMIBC presenting as papillary disease only (low grade \[Grade 1- Grade 2\], Ta or T1, with no previous CIS) received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
|---|---|---|---|---|
|
Cohort 1: Recurrence-Free Survival Rate at 6 Months and 12 Months
6-month survival rate
|
0.96 Proportion of participants
Interval 0.84 to 0.99
|
0.73 Proportion of participants
Interval 0.49 to 0.87
|
—
|
—
|
|
Cohort 1: Recurrence-Free Survival Rate at 6 Months and 12 Months
12-month survival rate
|
0.79 Proportion of participants
Interval 0.64 to 0.89
|
0.44 Proportion of participants
Interval 0.22 to 0.63
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 monthsPopulation: ITT analysis set included all randomized participants. Participants in Cohort 1 were primarily analyzed by the treatment to which they were assigned, regardless of the actual treatment received. Data for this outcome measure was planned to be collected and analyzed for specified arms only as planned in protocol.
Time to progression (TTP) was defined as the time from the date of randomization until the date of first documented evidence of any of the following: disease progression (PD) or death. PD included development of or increase in stage to lamina propria invasion (for example- increase from Ta to T1), development of or increase in stage to muscle-invasive disease (stage greater than or equal to \[\>=\] T2), development of or increase in stage to lymph node (N+) or distant metastasis (M1) disease (participants must have previously been diagnosed with N0 and/or M0 disease), increase in tumor grade from low to high (including CIS).
Outcome measures
| Measure |
Cohort 1: Erdafitinib
n=49 Participants
Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ \[CIS\], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 milligrams (mg) once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 1: Investigator's Choice
n=24 Participants
Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy and who either refused or were not eligible for cystectomy received the investigator's choice of treatment: either gemcitabine intravesical instillation (4 induction doses: 2000 mg once weekly on Days 1, 8, 15 and 22 of Cycle 1 followed by monthly maintenance dose on Day 1 of Cycle 2 to 7, each cycle of 28 days) or either mitomycin C (MMC) or hyperthermic MMC as an intravesical instillation at the dose of 40 mg/40 milliliter (mL). Additional doses of induction or maintenance were allowed per local standard of care. The choice of drug was determined by the investigator and treatment continued until its completion, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). Participants with locally confirmed high-risk recurrence on Investigator's Choice were offered an option to crossover treatment with erdafitinib until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 2: Erdafitinib
Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 3: Erdafitinib
Participants with intermediate-risk NMIBC presenting as papillary disease only (low grade \[Grade 1- Grade 2\], Ta or T1, with no previous CIS) received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
|---|---|---|---|---|
|
Cohort 1: Time to Progression
|
NA Months
Here 'NA' signifies that median, lower and upper limit of 95% CI could not be calculated as there were small number of participants with events due to early termination of the participants enrollment.
|
NA Months
Here 'NA' signifies that median, lower and upper limit of 95% CI could not be calculated as there were small number of participants with events due to early termination of the participants enrollment.
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 monthsPopulation: ITT analysis set included all randomized participants. Participants in Cohort 1 were primarily analyzed by the treatment to which they were assigned, regardless of the actual treatment received. Data for this outcome measure was planned to be collected and analyzed for specified arms only as planned in protocol.
Overall survival was defined as the time from the date of randomization to the date of the participant's death due to any cause.
Outcome measures
| Measure |
Cohort 1: Erdafitinib
n=49 Participants
Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ \[CIS\], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 milligrams (mg) once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 1: Investigator's Choice
n=24 Participants
Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy and who either refused or were not eligible for cystectomy received the investigator's choice of treatment: either gemcitabine intravesical instillation (4 induction doses: 2000 mg once weekly on Days 1, 8, 15 and 22 of Cycle 1 followed by monthly maintenance dose on Day 1 of Cycle 2 to 7, each cycle of 28 days) or either mitomycin C (MMC) or hyperthermic MMC as an intravesical instillation at the dose of 40 mg/40 milliliter (mL). Additional doses of induction or maintenance were allowed per local standard of care. The choice of drug was determined by the investigator and treatment continued until its completion, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). Participants with locally confirmed high-risk recurrence on Investigator's Choice were offered an option to crossover treatment with erdafitinib until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 2: Erdafitinib
Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 3: Erdafitinib
Participants with intermediate-risk NMIBC presenting as papillary disease only (low grade \[Grade 1- Grade 2\], Ta or T1, with no previous CIS) received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
|---|---|---|---|---|
|
Cohort 1: Overall Survival
|
NA Months
Here, 'NA' signifies that median, lower and upper limit of 95% CI could not be calculated as there were small number of participants with events due to early termination of the participants enrollment.
|
NA Months
Here, 'NA' signifies that median, lower and upper limit of 95% CI could not be calculated as there were small number of participants with events due to early termination of the participants enrollment.
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment (Day 1) up to 25.2 monthsPopulation: Safety analysis set included all participants who received at least 1 dose of study drug.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were the events between first dose of study drug and up to 30 (+7 days) days after last dose or before start of subsequent anticancer therapy, whichever occurred first. All TEAEs including serious and non-serious events were reported in this outcome measure (OM).
Outcome measures
| Measure |
Cohort 1: Erdafitinib
n=49 Participants
Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ \[CIS\], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 milligrams (mg) once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 1: Investigator's Choice
n=23 Participants
Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy and who either refused or were not eligible for cystectomy received the investigator's choice of treatment: either gemcitabine intravesical instillation (4 induction doses: 2000 mg once weekly on Days 1, 8, 15 and 22 of Cycle 1 followed by monthly maintenance dose on Day 1 of Cycle 2 to 7, each cycle of 28 days) or either mitomycin C (MMC) or hyperthermic MMC as an intravesical instillation at the dose of 40 mg/40 milliliter (mL). Additional doses of induction or maintenance were allowed per local standard of care. The choice of drug was determined by the investigator and treatment continued until its completion, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). Participants with locally confirmed high-risk recurrence on Investigator's Choice were offered an option to crossover treatment with erdafitinib until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 2: Erdafitinib
n=16 Participants
Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 3: Erdafitinib
n=18 Participants
Participants with intermediate-risk NMIBC presenting as papillary disease only (low grade \[Grade 1- Grade 2\], Ta or T1, with no previous CIS) received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
49 Participants
|
19 Participants
|
16 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: All cohorts: Pre-dose on Cycle 1 Day 14, pre-dose and 3 hours post-dose on Cycle 2 Day 1 (each cycle was of 28 days)Population: Pharmacokinetic (PK) evaluable analysis set: all randomized (Cohort 1) or treated (Cohort 2 and 3) participants who had received at least 1 dose of erdafitinib and had at least 1 PK sample obtained post-treatment. 'N' (overall number of participants analyzed): number of participants evaluable for this OM, 'n' (number analyzed): participants analyzed at specified time points. Data for this outcome measure was not planned to be collected and analyzed for 'Cohort 1: Investigator's Choice' arm.
Plasma concentrations of erdafitinib were reported. Plasma samples were analyzed using liquid chromatography/mass spectrometry method.
Outcome measures
| Measure |
Cohort 1: Erdafitinib
n=43 Participants
Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ \[CIS\], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 milligrams (mg) once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 1: Investigator's Choice
n=16 Participants
Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy and who either refused or were not eligible for cystectomy received the investigator's choice of treatment: either gemcitabine intravesical instillation (4 induction doses: 2000 mg once weekly on Days 1, 8, 15 and 22 of Cycle 1 followed by monthly maintenance dose on Day 1 of Cycle 2 to 7, each cycle of 28 days) or either mitomycin C (MMC) or hyperthermic MMC as an intravesical instillation at the dose of 40 mg/40 milliliter (mL). Additional doses of induction or maintenance were allowed per local standard of care. The choice of drug was determined by the investigator and treatment continued until its completion, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). Participants with locally confirmed high-risk recurrence on Investigator's Choice were offered an option to crossover treatment with erdafitinib until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 2: Erdafitinib
n=18 Participants
Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 3: Erdafitinib
Participants with intermediate-risk NMIBC presenting as papillary disease only (low grade \[Grade 1- Grade 2\], Ta or T1, with no previous CIS) received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
|---|---|---|---|---|
|
Plasma Concentrations of Erdafitinib
Cycle 1 Day 14: Predose
|
592 Nanograms per milliliter (ng/mL)
Standard Deviation 252
|
525 Nanograms per milliliter (ng/mL)
Standard Deviation 227
|
605 Nanograms per milliliter (ng/mL)
Standard Deviation 171
|
—
|
|
Plasma Concentrations of Erdafitinib
Cycle 2 Day 1: Predose
|
635 Nanograms per milliliter (ng/mL)
Standard Deviation 335
|
603 Nanograms per milliliter (ng/mL)
Standard Deviation 350
|
685 Nanograms per milliliter (ng/mL)
Standard Deviation 246
|
—
|
|
Plasma Concentrations of Erdafitinib
Cycle 2 Day 1: 3 hours post dose
|
750 Nanograms per milliliter (ng/mL)
Standard Deviation 367
|
739 Nanograms per milliliter (ng/mL)
Standard Deviation 337
|
709 Nanograms per milliliter (ng/mL)
Standard Deviation 220
|
—
|
Adverse Events
Cohort 1: Erdafitinib
Cohort 1: Investigator's Choice
Cohort 1: Crossover Participants From Investigator's Choice to Erdafitinib
Cohort 2: Erdafitinib
Cohort 3: Erdafitinib
Serious adverse events
| Measure |
Cohort 1: Erdafitinib
n=49 participants at risk
Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ \[CIS\], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 milligrams (mg) once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 1: Investigator's Choice
n=23 participants at risk
Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy and who either refused or were not eligible for cystectomy received the investigator's choice of treatment: either gemcitabine intravesical instillation (4 induction doses: 2000 mg once weekly on Days 1, 8, 15 and 22 of Cycle 1 followed by monthly maintenance dose on Day 1 of Cycle 2 to 7, each cycle of 28 days) or either mitomycin C (MMC) or hyperthermic MMC as an intravesical instillation at the dose of 40 mg/40 milliliter (mL). Additional doses of induction or maintenance were allowed per local standard of care. The choice of drug was determined by the investigator and treatment continued until its completion, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). Participants with locally confirmed high-risk recurrence on Investigator's Choice were offered an option to crossover treatment with erdafitinib until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 1: Crossover Participants From Investigator's Choice to Erdafitinib
n=9 participants at risk
Participants in Cohort 1 who initially received investigator's choice of treatment with locally confirmed high-risk recurrence on investigator's choice were offered an option to crossover at crossover screening visit and received erdafitinib tablets orally, at a dose of 6 mg once daily starting from crossover Cycle 1 Day 1 (Month 12) up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years) until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 2: Erdafitinib
n=16 participants at risk
Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 3: Erdafitinib
n=18 participants at risk
Participants with intermediate-risk NMIBC presenting as papillary disease only (low grade \[Grade 1- Grade 2\], Ta or T1, with no previous CIS) received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
|---|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Central Serous Chorioretinopathy
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
2/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Detachment of Macular Retinal Pigment Epithelium
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Keratitis
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Maculopathy
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
General disorders
Pyrexia
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Enterococcal Bacteraemia
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Pulmonary Sepsis
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Injury, poisoning and procedural complications
Brain Contusion
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine Carcinoma of the Skin
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Nervous system disorders
Syncope
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Renal and urinary disorders
Renal Colic
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Reproductive system and breast disorders
Prostatitis
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Vascular disorders
Hypotension
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Vascular disorders
Peripheral Artery Occlusion
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
Other adverse events
| Measure |
Cohort 1: Erdafitinib
n=49 participants at risk
Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ \[CIS\], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 milligrams (mg) once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 1: Investigator's Choice
n=23 participants at risk
Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy and who either refused or were not eligible for cystectomy received the investigator's choice of treatment: either gemcitabine intravesical instillation (4 induction doses: 2000 mg once weekly on Days 1, 8, 15 and 22 of Cycle 1 followed by monthly maintenance dose on Day 1 of Cycle 2 to 7, each cycle of 28 days) or either mitomycin C (MMC) or hyperthermic MMC as an intravesical instillation at the dose of 40 mg/40 milliliter (mL). Additional doses of induction or maintenance were allowed per local standard of care. The choice of drug was determined by the investigator and treatment continued until its completion, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). Participants with locally confirmed high-risk recurrence on Investigator's Choice were offered an option to crossover treatment with erdafitinib until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 1: Crossover Participants From Investigator's Choice to Erdafitinib
n=9 participants at risk
Participants in Cohort 1 who initially received investigator's choice of treatment with locally confirmed high-risk recurrence on investigator's choice were offered an option to crossover at crossover screening visit and received erdafitinib tablets orally, at a dose of 6 mg once daily starting from crossover Cycle 1 Day 1 (Month 12) up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years) until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 2: Erdafitinib
n=16 participants at risk
Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
Cohort 3: Erdafitinib
n=18 participants at risk
Participants with intermediate-risk NMIBC presenting as papillary disease only (low grade \[Grade 1- Grade 2\], Ta or T1, with no previous CIS) received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
8.7%
2/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Congenital, familial and genetic disorders
Corneal Dystrophy
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Ear and labyrinth disorders
Tympanic Membrane Perforation
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Blepharitis
|
10.2%
5/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Cataract
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
18.8%
3/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Cataract Subcapsular
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Central Serous Chorioretinopathy
|
22.4%
11/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
33.3%
3/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Corneal Scar
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Detachment of Retinal Pigment Epithelium
|
10.2%
5/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Dry Age-Related Macular Degeneration
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Dry Eye
|
22.4%
11/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
25.0%
4/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
27.8%
5/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Eye Discharge
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Eye Pain
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Eyelid Oedema
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Glaucoma
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Keratitis
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Keratopathy
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Lacrimation Increased
|
16.3%
8/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Metamorphopsia
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Ocular Hyperaemia
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Optic Disc Disorder
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Photophobia
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Punctate Keratitis
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Retinal Dystrophy
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Retinal Exudates
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Retinal Vein Occlusion
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Retinopathy
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Serous Retinal Detachment
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Subretinal Fluid
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Subretinal Hyperreflective Exudation
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Swelling of Eyelid
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Ulcerative Keratitis
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Vision Blurred
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
4/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Visual Acuity Reduced
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Visual Impairment
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Vitreous Detachment
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Vitreous Floaters
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Abdominal Distension
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.2%
6/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
27.8%
5/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Chapped Lips
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Cheilitis
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Constipation
|
20.4%
10/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
31.2%
5/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
44.4%
8/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
59.2%
29/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
13.0%
3/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
44.4%
4/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
56.2%
9/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
83.3%
15/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Dry Mouth
|
46.9%
23/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
66.7%
6/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
56.2%
9/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
72.2%
13/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
7/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
2/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
4/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Dysphagia
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Faeces Soft
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Gingival Ulceration
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Glossitis
|
8.2%
4/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Lip Blister
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Lip Dry
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Lip Ulceration
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Nausea
|
10.2%
5/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
18.8%
3/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
27.8%
5/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Oral Dysaesthesia
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Stomatitis
|
44.9%
22/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
33.3%
3/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
50.0%
8/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
27.8%
5/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
General disorders
Asthenia
|
10.2%
5/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
18.8%
3/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
4/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
General disorders
Enanthema
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
General disorders
Fatigue
|
18.4%
9/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
2/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
18.8%
3/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
38.9%
7/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
General disorders
Mucosal Inflammation
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
General disorders
Oedema Peripheral
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
8.7%
2/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
General disorders
Pain
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
General disorders
Pyrexia
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
General disorders
Temperature Intolerance
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Balanitis Candida
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Candida Infection
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Conjunctivitis
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Covid-19
|
12.2%
6/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Cystitis
|
8.2%
4/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
8.7%
2/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Eye Infection
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Folliculitis
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Influenza
|
8.2%
4/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Nail Infection
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Oral Candidiasis
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Oral Fungal Infection
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Orchitis
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Paronychia
|
16.3%
8/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
4/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Pneumonia
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Urinary Tract Infection
|
18.4%
9/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
13.0%
3/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
2/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
31.2%
5/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
4/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Injury, poisoning and procedural complications
Injury Corneal
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Investigations
Alanine Aminotransferase Increased
|
12.2%
6/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
8.7%
2/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
31.2%
5/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
16.7%
3/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Investigations
Aspartate Aminotransferase Increased
|
12.2%
6/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
13.0%
3/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
18.8%
3/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
16.7%
3/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Investigations
Blood Calcium Increased
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Investigations
Blood Creatinine Increased
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Investigations
Blood Parathyroid Hormone Increased
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Investigations
Blood Phosphorus Decreased
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Investigations
Blood Phosphorus Increased
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Investigations
Cardiac Murmur
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Investigations
Intraocular Pressure Increased
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Investigations
Lipase Increased
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Investigations
Ophthalmological Examination Abnormal
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Investigations
Weight Decreased
|
14.3%
7/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
31.2%
5/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
27.8%
5/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
22.4%
11/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
2/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
4/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
73.5%
36/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
66.7%
6/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
56.2%
9/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
100.0%
18/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Metabolism and nutrition disorders
Hyperphosphatasaemia
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
18.8%
3/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.2%
4/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
8.7%
2/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Musculoskeletal and connective tissue disorders
Bone Swelling
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
8.2%
4/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Nervous system disorders
Ageusia
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Nervous system disorders
Dizziness
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
2/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Nervous system disorders
Dysgeusia
|
22.4%
11/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
43.8%
7/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
55.6%
10/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Nervous system disorders
Headache
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
8.7%
2/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
4/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Nervous system disorders
Paraesthesia
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Nervous system disorders
Taste Disorder
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Psychiatric disorders
Depression
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Psychiatric disorders
Insomnia
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
25.0%
4/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Psychiatric disorders
Libido Decreased
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
8.7%
2/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Renal and urinary disorders
Dysuria
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
13.0%
3/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
18.8%
3/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Renal and urinary disorders
Haematuria
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
13.0%
3/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
25.0%
4/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Renal and urinary disorders
Pollakiuria
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
8.7%
2/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Renal and urinary disorders
Renal Impairment
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Renal and urinary disorders
Strangury
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Reproductive system and breast disorders
Epididymal Cyst
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Reproductive system and breast disorders
Genital Lesion
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Reproductive system and breast disorders
Penile Erosion
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Reproductive system and breast disorders
Scrotal Dermatitis
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Reproductive system and breast disorders
Testicular Atrophy
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
17.4%
4/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
7/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
2/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
4/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
8.2%
4/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
33.3%
6/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Obstruction
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.4%
10/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
2/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
18.8%
3/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
33.3%
6/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
24.5%
12/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
33.3%
3/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
43.8%
7/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
50.0%
9/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Eczema Asteatotic
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Hair Colour Changes
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Hair Texture Abnormal
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
10.2%
5/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Nail Bed Inflammation
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Nail Discolouration
|
10.2%
5/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
2/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
2/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
14.3%
7/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
37.5%
6/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
27.8%
5/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Nail Dystrophy
|
32.7%
16/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
33.3%
3/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
22.2%
4/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Nail Hypertrophy
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Nail Toxicity
|
8.2%
4/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
20.4%
10/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
18.8%
3/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
27.8%
5/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
18.8%
3/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
12.2%
6/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
31.2%
5/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
38.9%
7/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
25.0%
4/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
4.1%
2/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
12.5%
2/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
6.2%
1/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Vascular disorders
Hypertension
|
2.0%
1/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
4.3%
1/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
25.0%
4/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Vascular disorders
Hypotension
|
6.1%
3/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Vascular disorders
Superficial Vein Thrombosis
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
11.1%
1/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
|
Vascular disorders
Varicose Vein
|
0.00%
0/49 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/23 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/9 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
0.00%
0/16 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
5.6%
1/18 • Cohort (C) 1 (Erdafitinib and Investigators Choice), C2 and C3: All cause mortality: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months; Serious AEs/Other AEs: From start of treatment (Day 1 of Cycle 1) up to 30(+7 days) days after last dose (up to 25.2 months), C1 crossover participants: All cause mortality: Screening crossover visit (Month 12) up to 48.2 months; Serious AEs/Other AEs: Screening crossover visit (Month 12) up to 30(+7 days) days after last dose (up to 25.2 months)
All cause mortality: analyzed on all randomized participants, Serious AEs (SAEs) and Other AEs: Safety analysis set included all participants who received at least 1 dose of study drug. AEs were collected and analyzed collectively in investigator's arm for gemcitabine or mitomycin C (MMC)/hyperthermic MMC. Per plan safety was analyzed per intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER