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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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The Phase IIIb NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with investigator-selected cisplatin-based neoadjuvant chemotherapy (either ddMVAC or gemcitabine/cisplatin) in a clinical practice setting.

Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)

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A Phase IIIb, Open-label, Single-arm, Global Study of Perioperative Durvalumab With Neoadjuvant ddMVAC or Gem/Cis in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)

Incidence of Grade 3 or 4 [possibly treatment-related adverse events (PRAEs)] as observed prior to RC.

Incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of treatment-emergent adverse events, including PRAEs, adverse events of special interest, immune-mediated adverse events, adverse events (AEs), and serious adverse events; AEs resulting in study treatment interruption and discontinuation; laboratory findings.

EFS is defined as the time from first neoadjuvant durvalumab + chemotherapy treatment until the earliest occurrence of any of the following events:
• First recurrence of disease after RC
• First documented progression in participants who were medically precluded from RC
• Time of expected surgery in participants who refuse to undergo RC or failure to undergo RC in participants with residual disease
• Death due to any cause.

DFS is defined as the time from the date of RC to the earliest of the first recurrence of disease post RC or death due to any cause.

OS is defined as the time from first neoadjuvant durvalumab + chemotherapy until death due to any cause.

pCR rate is defined as the proportion of participants whose pathologic staging is T0N0M0 as assessed per local pathology review using specimens obtained via RC.

pDS rate is defined as the proportion of participants whose pathologic staging is <P2 per local pathology review using specimens obtained via RC.

Arms	Assigned Interventions
Experimental: ddMVAC cohort Durvalumab + chemotherapy	Drug: Durvalumab Anti- PD-L1 Antibody. Drug: Methotrexate Chemotherapy agent. Drug: Vinblastine Chemotherapy agent Drug: Doxorubicin Chemotherapy agent Drug: Cisplatin Chemotherapy agent
Experimental: gem/cis cohort Durvalumab + chemotherapy	Drug: Durvalumab Anti- PD-L1 Antibody Drug: Gemcitabine Chemotherapy agent Drug: Cisplatin Chemotherapy agent

Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)

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