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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

107 participants

Primary outcome timeframe

From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months

Results posted on

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

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

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

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 months

Population: 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

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 12

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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

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

Serious events: 13 serious events
Other events: 49 other events
Deaths: 5 deaths

Cohort 1: Investigator's Choice

Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths

Cohort 1: Crossover Participants From Investigator's Choice to Erdafitinib

Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths

Cohort 2: Erdafitinib

Serious events: 4 serious events
Other events: 16 other events
Deaths: 1 deaths

Cohort 3: Erdafitinib

Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths

Serious adverse events

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

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

Clinical Leader

Janssen Research & Development, LLC

Phone: 844-434-4210

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