A Clinical Study of ONCT-534 in Subjects With Metastatic... | NCT05917470

Label	Type	Description	Intervention Names
Dose Level 1: 40mg QD	Experimental	40mg of single agent ONCT-534 to be administered daily in oral tablets	Drug: ONCT-534
Dose Level 2: 80mg QD	Experimental	80mg of single agent ONCT-534 to be administered daily in oral tablets	Drug: ONCT-534
Dose Level 3: 160mg QD	Experimental	160mg of single agent ONCT-534 to be administered daily in oral tablets	Drug: ONCT-534
Dose Level 4: 300mg QD	Experimental	300mg of single agent ONCT-534 to be administered daily in oral tablets	Drug: ONCT-534
Dose Level 5: 600mg QD	Experimental	600mg of single agent ONCT-534 to be administered daily in oral tablets	Drug: ONCT-534
Dose Level 6: 1200 mg QD	Experimental	1200mg of single agent ONCT-534 to be administered daily in oral tablets

Name	Type	Description	Arm Group Labels	Other Names
ONCT-534	Drug	ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.

Measure	Description	Time Frame
Dose Limiting Toxicities Through Study Day 28	Incidence of DLTs through Study Day 28	Number of Participants with Dose Limiting Toxicities Through Study Day 28

Measure	Description	Time Frame
Reduction of Prostate-Specific Antigen (PSA) by More Than 50%	Proportion of patients who achieve at least a 50% drop in PSA from baseline (PSA50)	Up to 51 Weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is ≥18 years of age
Subject has histologically documented metastatic adenocarcinoma of the prostate confirmed by biopsy without neuroendocrine differentiation or small cell features.
Subjects has a history of metastatic CRPC.
Subject has R/R disease following treatment with at least one next-generation AR-signaling inhibitor.
Subject has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or evaluable bony disease. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
Subject has an Eastern Cooperative Oncology Group performance status of 0,1 or 2, and life expectancy of ≥ 6 months.
Subject agrees to take or continue luteinizing hormone-releasing hormone agonist or antagonist therapy or has undergone bilateral orchiectomy.
At least 2 weeks or five half-lives have elapsed, whichever is earliest, since last systemic therapy, including taxanes or other chemotherapy. At least one month has elapsed since systemic therapy with radionuclide pharmaceutical agents
Subject has evidence of disease progression on or after their most recent systemic treatment
Subject has a PSA level ≥ 10 ng/mL, or ≥ 2 ng/mL and ≥ 50% increase from nadir on prior therapy, whichever is lowest.
Subject has serum testosterone < 50 ng/dL.
Subject has adequate renal, hepatic, and pulmonary function
Subject is committed to practice true abstinence, or use a highly effective method of contraception with any female partner of childbearing potential unless documented to be surgically sterile (i.e., vasectomy or bilateral orchiectomy) and to not make semen donations during the study and for 3 months after the last dose of study drug.

Exclusion Criteria:

Subject has small cell prostate cancer or neuroendocrine disease histology, including mixed histology.
Subject has metastases to the brain or central nervous system
Subject is receiving concurrent anti-cancer therapy (including chemotherapy, antibody therapy, immunotherapy, cellular therapy, or other experimental therapies) except for ongoing androgen inhibiting therapy such as luteinizing hormone-releasing hormone (LHRH) agonists. Supportive non-cancer directed therapies such as bisphosphonates or denosumab are allowed.
Subjects taking a strong inhibitor of CYP3A4 or a substrate of CYP2C9 or CYP2C19
Subject had major surgery within 30 days prior to start of study drug.
Subject has current, untreated pathologic long-bone fractures(s), or risk of imminent pathologic fracture(s).
Subject has current or imminent spinal cord compression.
Subject has an active seizure disorder or a history of seizure disorder(s).
Subject has evidence of active human immunodeficiency virus infection, hepatitis B virus (HBV), or hepatitis C virus (HCV)
Subject has any other serious illness or medical condition that would interfere with study participation
Subject has abnormal electrocardiograms (ECGs) that are clinically significant, including average QTcF > 450 ms, or a history of Torsade de Pointes.
Subject has any infection requiring parenteral antibiotic therapy or causing fever (temperature >100.5°F or 38.1°C) within 1 week prior to first dose.
Clinically significant other malignancy with the potential to confound study assessments, with the exception of e.g., treated cutaneous squamous cell and basal carcinomas, non-muscle invasive bladder cancer, Rai Stage 0 CLL, and adequately treated Stage 1 to 2 non-cutaneous malignancy in remission for 5 years.
Subject is unable to comply with the protocol and/or not willing or not available for follow-up assessments
Subject has any medical intervention or other condition which, in the opinion of the Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives.

Name	Affiliation	Role
Salim Yazji, MD	Oncternal Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Francisco		San Francisco	California	94143	United States
Karmanos Cancer Institute

ID	Title	Description
FG000	Dose Level 1: 40mg QD	40mg QD of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 6, 2024

Arm/Group Information

ID	Title	Description
BG000	Dose Level 1: 40mg QD	40mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
BG001	Dose Level 2: 80mg QD	80mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
BG002	Dose Level 3: 160mg QD	160mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
BG003	Dose Level 4: 300mg QD	300mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
BG004	Dose Level 5: 600mg QD	600mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
BG005	Dose Level 6: 1200 mg QD	1200mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
BG006	BID Dose Level 1: 160 mg BID	600mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
BG007	BID Dose Level 2: 300 mg BID	300mg of single agent ONCT-534 to be administered twice daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
BG008	Total	Total of all reporting groups

Units	Counts
Participants	BG0001 BG0011 BG0024 BG0033 BG0043 BG0053 BG0063 BG0073 BG00821

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Dose Limiting Toxicities Through Study Day 28

Incidence of DLTs through Study Day 28

DLT-evaluable population

Posted

Count of Participants

Participants

Number of Participants with Dose Limiting Toxicities Through Study Day 28

ID	Title	Description
OG000	Dose Level 1: 40mg QD	40mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
OG001	Dose Level 2: 80mg QD	80mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
OG002	Dose Level 3: 160mg QD	160mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
OG003	Dose Level 4: 300mg QD	300mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
OG004	Dose Level 5: 600mg QD	600mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
OG005	Dose Level 6: 1200 mg QD	1200mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
OG006	BID Dose Level 1: 160 mg BID	600mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
OG007	BID Dose Level 2: 300 mg BID	300mg of single agent ONCT-534 to be administered twice daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.

Units	Counts
Participants	OG0001 OG0011 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Secondary

Reduction of Prostate-Specific Antigen (PSA) by More Than 50%

Proportion of patients who achieve at least a 50% drop in PSA from baseline (PSA50)

Efficacy-evaluable population

Posted

Count of Participants

Participants

Up to 51 Weeks

ID	Title	Description
OG000	Dose Level 1: 40mg QD	40mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
OG001	Dose Level 2: 80mg QD	80mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.

Post-Hoc

Number of Subjects With Any Post-Baseline Decrease in PSA

Any reduction in PSA after Baseline (First Day of Treatment)

Efficacy-evaluable Population

Posted

Count of Participants

Participants

Up to 51 Weeks

ID	Title	Description
OG000	Dose Level 1: 40mg QD	40mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
OG001	Dose Level 2: 80mg QD	80mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dose Level 1: 40mg QD	40mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.	0	1	1	1	1	1
EG001	Dose Level 2: 80mg QD	80mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.	0	1	0	1	0	1
EG002	Dose Level 3: 160mg QD	160mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.	1	4	2	4	4	4
EG003	Dose Level 4: 300mg QD	300mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.	0	3	1	3	3	3
EG004	Dose Level 5: 600mg QD	600mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.	0	3	1	3	3	3
EG005	Dose Level 6: 1200 mg QD	1200mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.	0	3	2	3	3	3
EG006	BID Dose Level 1: 160 mg BID	600mg of single agent ONCT-534 to be administered daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.	0	3	0	3	3	3
EG007	BID Dose Level 2: 300 mg BID	300mg of single agent ONCT-534 to be administered twice daily in oral tablets ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.	0	3	0	3	3	3

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG0030 events0 affected3 at risk EG0042 events1 affected3 at risk EG0050 events0 affected3 at risk EG0060 events0 affected3 at risk EG0070 events0 affected3 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected4 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Atypical Haemolytic Uraemic Syndrome	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Lactic Acidosis	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected4 at risk EG003
Non-cardiac Chest Pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Retinal Artery Occlusion	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Seroma	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Spinal Cord Compression	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Urinary Tract Obstruction	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected4 at risk EG003
Urosepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected4 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG0031 events1 affected3 at risk EG0041 events1 affected3 at risk EG0050 events0 affected3 at risk EG0060 events0 affected3 at risk EG0070 events0 affected3 at risk
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0022 events2 affected4 at risk EG003
Flushing	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Hot Flush	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Lumbroscral Plexopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Paresthesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected4 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected4 at risk EG003
Blood Alkaline Phosphatase Increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected4 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0022 events2 affected4 at risk EG003
Gastrointestinal Disorder	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected4 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected4 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0022 events2 affected4 at risk EG003
Urinary Retention	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected4 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected4 at risk EG003
Blood Creatinine Increase	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Extradural Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
International Normalised Ratio Increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Spinal Cord Compression	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Blood Lactate Dehydrogenase Increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Oedema Peripheral	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Pelvic Pain	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Acute Kidney Injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Atrioventricular Block First Degree	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Blood Bilirubin Increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Platelet Count Decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Urinary Incontinence	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Photosensitivity Reaction	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Blood Creatinine Phophokinase Increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected4 at risk EG003

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases