Secondary

Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30

EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies.

Secondary

Change from Baseline in EuroQol European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L)

EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression.

Secondary

Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24

EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with superficial (non-muscle-invasive) bladder cancer. The questionnaire is designed to supplement the QLQ-C30.

Secondary

Change from Baseline in Patient's Global Impression of Change (of cancer) (PGIC)

PGIC is single-item questionnaires to evaluate a patient's global impression of change of cancer.

Secondary

Recurrence-Free Survival

RFS is defined as the time from the date of randomization until the date of the reappearance of high-risk disease, or death, whichever is reported first. Participants who are recurrence-free and alive or have unknown status will be censored at the last tumor assessment.

Secondary

Number of Participants with Adverse events

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product

Secondary

Plasma Concentration of Erdafitinib

Plasma concentration of erdafitinib will be reported.

Secondary

RFS by Central Histopathologic Review

RFS will be assessed by central histopathologic review. RFS is defined as the time from the date of randomization until the date of the reappearance of high-risk disease, or death, whichever is reported first.

Secondary

Recurrence-Free Survival 2 (RFS2)

RFS2 is defined as the time from the date of randomization until the date of the reappearance of high-risk disease on the first subsequent non-surgical anticancer treatment, or death, whichever is reported first.

Secondary

Overall Survival

The time from the date of randomization to the date of the participant's death resulting from any cause. Participants who are alive or have unknown vital status will be censored at the date the participant was last known to be alive.

Secondary

Disease-Specific Survival

The time from the date of randomization to the date of the participant's death resulting from bladder cancer. Participants who are alive or have unknown vital status will be censored at the date the participant was last known to be alive. Participants whose death result from causes other than bladder cancer will be censored at their death dates.

Secondary

Time to Progression

Time from the date of randomization until the date of first documented evidence of any of progression or death. Participants who are progression -free and alive or have unknown status will be censored at the date of the last tumor assessment.

Secondary

Time to Disease Worsening

Time from the date of randomization to the date of first documented evidence of cystectomy, change in therapy indicative of more advanced disease (including systemic chemotherapy or radiotherapy). Participants who are free of disease worsening and alive or have unknown status will be censored at the last tumor assessment.

Secondary

Change from Baseline in Patient's Global Impression of Severity (of cancer) (PGIS)

PGIS is single-item questionnaires to evaluate patient's global impression of severity.