Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey Long-term Use Survey in Prostate Cancer Patients (96 Weeks)

Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

Time frame: Baseline up to Week 96

Population: The safety analysis set was defined as all participants who were enrolled and completed the study.

Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Time frame: Baseline up to Week 96

Population: The safety analysis set was defined as all participants who were enrolled and completed the study.

Disease-specific survival is defined as time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.

Time frame: Baseline up to 96 weeks

Population: No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed.

Time frame: Baseline up to 96 weeks

Population: No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed.

OS was defined as the duration from randomization to death (due to any cause). Probability of OS was reported using Kaplan-Meier method. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=\<2 centimeter (cm), T2=2-5 cm, T3=\>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.

Time frame: Baseline up to 96 weeks or death (which ever occurs first)

Population: The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available.

PFS was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=\<2 centimeter (cm), T2=2-5 cm, T3=\>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.

Time frame: Baseline up to 96 weeks

Population: The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available.