Trial Outcomes & Findings for Teverelix Evaluated in Advanced Prostate Cancer (NCT NCT04693507)

NCT ID: NCT04693507

Last Updated: 2024-07-23

Results Overview

Proportion of participants achieving castration level with serum T \<0.5 ng/mL at Day 28.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2024-07-23

Participant Flow

Participant milestones

Measure	Teverelix TFA 120 mg 6-weekly Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Overall Study STARTED	9	41
Overall Study COMPLETED	5	32
Overall Study NOT COMPLETED	4	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Teverelix Evaluated in Advanced Prostate Cancer

Baseline characteristics by cohort

Measure	Teverelix TFA 120 mg 6-weekly n=9 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=41 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	32 Participants n=7 Participants	39 Participants n=5 Participants
Age, Continuous	69.0 years STANDARD_DEVIATION 5.12 • n=5 Participants	69.0 years STANDARD_DEVIATION 7.33 • n=7 Participants	69.0 years STANDARD_DEVIATION 6.94 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	41 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants	41 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment Lithuania	9 Participants n=5 Participants	41 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Proportion of participants achieving castration level with serum T <0.5 ng/mL at Day 28.

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=9 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=41 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Testosterone (T) Levels (Castrate) at Week 4	5 Participants	39 Participants

SECONDARY outcome

Timeframe: 4 weeks

Proportion of participants achieving castration level with serum T <0.2 ng/mL at Day 28

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=9 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=41 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Testosterone (T) Levels (0.2 ng/mL) at Week 4	2 Participants	32 Participants

SECONDARY outcome

Timeframe: 6 weeks

Proportion of participants achieving castration level with serum T <0.5 ng/mL at Day 42

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=9 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=41 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Testosterone (T) Levels (Castrate) at Week 6	4 Participants	33 Participants

SECONDARY outcome

Timeframe: 6 weeks

Proportion of participants achieving profound castration level (0.2 ng/mL) with serum T <0.5 ng/mL at Day 42

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=9 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=41 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Testosterone (T) Levels (0.2 ng/mL) at Week 6	1 Participants	26 Participants

SECONDARY outcome

Timeframe: 24 weeks

Proportion of participants achieving a T castration rate over 168 days of treatment period

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=9 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=41 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Testosterone Levels (Castrate) at Week 24	3 Participants	27 Participants

SECONDARY outcome

Timeframe: 24 weeks

Proportion of participants achieving profound castration rate (<0.2 ng/mL) over 168 days of treatment period

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=9 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=41 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Testosterone Levels (0.2 ng/mL) at Week 24	0 Participants	17 Participants

SECONDARY outcome

Timeframe: 4 weeks

Mean time to T levels falling below castration level (<0.5 ng/mL) for the first time

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=40 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Time to Achieve Castrate Levels of Testosterone (T)	2.0 days Interval 1.0 to 3.0	2.0 days Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: Approximately 30 weeks

Mean time to (first) overstep of T castration level after achieving castration

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=40 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Time to Escape Castrate Levels of Testosterone (T)	2.5 days Interval 1.0 to 123.0	215.0 days Interval 42.0 to 236.0

SECONDARY outcome

Timeframe: 4 weeks

Proportion of participants achieving castration level for LH (LH <1.1 U/L) at Day 28

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=9 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=41 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Luteinizing Hormone (LH) Levels (Castrate) at Week 4	5 Participants	38 Participants

SECONDARY outcome

Timeframe: 24 weeks

Proportion of participants with effective LH castration rate over 168 days of treatment period

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=9 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=41 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Luteinizing Hormone (LH) Levels (Castrate) at Week 24	2 Participants	22 Participants

SECONDARY outcome

Timeframe: 4 weeks

Mean time to LH levels falling below castration level (LH <1.1 U/L) for the first time

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=40 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Time to Achieve Castrate Levels of Luteinizing Hormone (LH)	1.0 days Interval 1.0 to 1.0	1.0 days Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: 24 weeks

Mean time to (first) overstep of LH castration level after achieving castration

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=40 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Time to Escape Castrate Levels of Luteinizing Hormone (LH)	4.5 days Interval 2.0 to 83.0	8.5 days Interval 2.0 to 42.0

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

The change in testosterone levels over time (Change from Baseline at Day 168)

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=40 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Change in Testosterone Levels Over Time (Change From Baseline at Day 168)	-16.68 nmol/L Standard Deviation 5.43	-20.26 nmol/L Standard Deviation 7.37

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

The change in LH levels over time

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=40 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Change in LH Levels Over Time	-69.8825 IU/L Standard Deviation 22.99177	-83.3425 IU/L Standard Deviation 26.87486

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

The change in FSH levels over time

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=40 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Change in FSH Levels Over Time	-71.8909 IU/L Standard Deviation 12.83868	-82.3272 IU/L Standard Deviation 12.67620

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

Area under the concentration time-curve from time zero up to the last quantifiable concentration at time point t (Ct), calculated using the linear up/log down trapezoidal rule.

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=39 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Area Under the Concentration Time-curve From Time Zero up to the Last Quantifiable Concentration at Time Point t (AUC0-t)	16007 h*ng/mL Interval 10118.4 to 25316.4	27511 h*ng/mL Interval 23235.6 to 32573.7

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

Area under the concentration time-curve from time zero up to the concentration at time point t1 after which the concentrations start to rise again towards a second peak, calculated using the linear up/log down trapezoidal rule. t1 will be determined after review of the concentration-time profiles (immediate release component of total observed AUC).

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=39 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Area Under the Concentration Time-curve From Time Zero up to the Concentration at Time Point t1 After Which the Concentrations Start to Rise Again Towards a Second Peak (AUC0-t1)	1324.3 h*ng/mL Interval 928.2 to 1892.1	1759.3 h*ng/mL Interval 1581.0 to 1958.4

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

The maximum observed plasma teverelix concentration after administration (Cmax)

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=39 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Maximum Observed Plasma Teverelix Concentration After Administration (Cmax)	38.22 ng/mL Interval 30.6 to 45.9	53.1 ng/mL Interval 45.9 to 56.1

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

The maximum observed concentration after administration from zero up to time point t1 (Cmax,0-t1)

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=39 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Maximum Observed Concentration After Administration From Zero up to Time Point t1 (Cmax,0-t1)	38.22 ng/mL Interval 30.6 to 45.9	53.1 ng/mL Interval 45.9 to 56.1

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

The maximum observed concentration after administration from time point t1 up to time point t (Cmax,t1-t)

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=40 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Maximum Observed Concentration After Administration From Time Point t1 up to Time Point t (Cmax,t1-t)	16.9 ng/mL Interval 10.2 to 25.5	20.4 ng/mL Interval 20.4 to 25.5

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

The time to reach Cmax after dosing (tmax)

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=39 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Time to Reach Cmax After Dosing (Tmax)	1.8 hours Interval 1.0 to 2.6	1.5 hours Interval 0.9 to 3.2

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

The time to reach Cmax,0-t1 after dosing (tmax,0-t1)

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=39 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Time to Reach Cmax,0-t1 After Dosing (Tmax,0-t1)	1.8 hours Interval 1.0 to 2.6	1.5 hours Interval 0.9 to 3.2

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

The time to reach Cmax,t1-t after dosing (tmax,t1-t)

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=39 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Time to Reach Cmax,t1-t After Dosing (Tmax,t1-t)	96.0 hours Interval 72.0 to 333.6	167 hours Interval 71.0 to 527.9

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

The apparent terminal elimination rate constant (lambda-z)

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=39 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Apparent Terminal Elimination Rate Constant (Lambda-z)	0 L/h Interval 0.0 to 0.0	0 L/h Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

Apparent terminal plasma half-life, calculated as: ln 2 / lambda-z

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=39 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Apparent Terminal Plasma Half-life (t½)	1380.3 hours Interval 198.5 to 7827.0	1103.1 hours Interval 209.7 to 4242.0

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

Area under the concentration time-curve from time zero up to infinity (∞),calculated using the linear up/log down trapezoidal rule.

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=39 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Area Under the Concentration Time-curve From Time Zero up to Infinity (∞)(AUC0-∞)	24888 h*ng/mL Interval 12693.9 to 48796.8	35794 h*ng/mL Interval 29952.3 to 42778.8

SECONDARY outcome

Timeframe: 24 weeks

Number of participants with a PSA response of ≥50 percent reduction at the Day 168 visit

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=40 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Prostate Specific Antigen (PSA) Reduction (≥50 Percent)	5 Participants	30 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

PSA response is defined as >50% decline in PSA at Day 28. PSA response rate is the number of subjects with a PSA response.

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=40 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
PSA Response Rate at Day 28	6 Participants	35 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

The number of subjects with a PSA response ≥50% at Day 168

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=40 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
PSA Response ≥50% at Day 168	5 Participants	30 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

Luteinizing Hormone (LH) - the mean % reduction at Day 168

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=40 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Luteinizing Hormone (LH) Mean % Reduction at Day 168	-69.88 % of baseline value Standard Deviation 22.99	-83.34 % of baseline value Standard Deviation 26.87

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

Testosterone (T) - the mean % reduction at Day 168

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=40 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Testosterone (T) Mean % Reduction at Day 168	-91.1 % of baseline Standard Deviation 7.02	-95.9 % of baseline Standard Deviation 4.57

SECONDARY outcome

Timeframe: 24 weeks

Population: Per Protocol

Follicle Stimulating Hormone (FSH) - the mean % reduction at Day 168

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=8 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=40 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Follicle Stimulating Hormone (FSH) Mean % Reduction at Day 168	-71.89 % of baseline Standard Deviation 12.84	-82.33 % of baseline Standard Deviation 12.68

SECONDARY outcome

Timeframe: 24 weeks

Population: Safety Population

Number of participants with treatment-emergent AEs

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=9 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=41 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Treatment-emergent Adverse Events (AEs)	8 Participants	38 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Safety Population

ECG QTcF Interval prolongation >450 msec at Day 28 study visit

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=9 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=41 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
ECG QTcF Interval Prolongation >450 Msec at Day 28	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Safety Population

Number of participants with ISRs at each visit during the 168 days treatment period

Outcome measures

Measure	Teverelix TFA 120 mg 6-weekly n=9 Participants Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=41 Participants Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Injection Site Reactions (ISRs)	5 Participants	26 Participants

Adverse Events

Teverelix TFA 120 mg 6-weekly

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Teverelix TFA 180 mg 6-weekly

Serious events: 1 serious events

Other events: 38 other events

Deaths: 1 deaths

Serious adverse events

Measure	Teverelix TFA 120 mg 6-weekly n=9 participants at risk Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=41 participants at risk Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
Vascular disorders Left Carotid Artery Stenosis	11.1% 1/9 • Number of events 1 • Until 30 days after last injection of study drug	0.00% 0/41 • Until 30 days after last injection of study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) benign pituitary tumour	11.1% 1/9 • Number of events 1 • Until 30 days after last injection of study drug	0.00% 0/41 • Until 30 days after last injection of study drug
Cardiac disorders cardiac arrest	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug

Other adverse events

Measure	Teverelix TFA 120 mg 6-weekly n=9 participants at risk Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24	Teverelix TFA 180 mg 6-weekly n=41 participants at risk Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
General disorders Injection site induration	77.8% 7/9 • Number of events 7 • Until 30 days after last injection of study drug	73.2% 30/41 • Number of events 30 • Until 30 days after last injection of study drug
General disorders Injection site erythema	66.7% 6/9 • Number of events 6 • Until 30 days after last injection of study drug	70.7% 29/41 • Number of events 29 • Until 30 days after last injection of study drug
General disorders Injection site swelling	33.3% 3/9 • Number of events 3 • Until 30 days after last injection of study drug	12.2% 5/41 • Number of events 5 • Until 30 days after last injection of study drug
General disorders Induration	0.00% 0/9 • Until 30 days after last injection of study drug	7.3% 3/41 • Number of events 3 • Until 30 days after last injection of study drug
General disorders Injection site pain	22.2% 2/9 • Number of events 2 • Until 30 days after last injection of study drug	0.00% 0/41 • Until 30 days after last injection of study drug
General disorders Pyrexia	0.00% 0/9 • Until 30 days after last injection of study drug	4.9% 2/41 • Number of events 2 • Until 30 days after last injection of study drug
Vascular disorders Hot flush	44.4% 4/9 • Number of events 4 • Until 30 days after last injection of study drug	41.5% 17/41 • Number of events 17 • Until 30 days after last injection of study drug
Investigations Electrocardiogram qt prolonged	0.00% 0/9 • Until 30 days after last injection of study drug	12.2% 5/41 • Number of events 5 • Until 30 days after last injection of study drug
Investigations Alanine aminotransferase increased	0.00% 0/9 • Until 30 days after last injection of study drug	7.3% 3/41 • Number of events 3 • Until 30 days after last injection of study drug
Investigations Aspartate aminotransferase increased	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Investigations Gamma-glutamyltransferase increased	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Cardiac disorders Atrial fibrillation	0.00% 0/9 • Until 30 days after last injection of study drug	9.8% 4/41 • Number of events 4 • Until 30 days after last injection of study drug
Cardiac disorders Sinus bradycardia	0.00% 0/9 • Until 30 days after last injection of study drug	4.9% 2/41 • Number of events 2 • Until 30 days after last injection of study drug
Cardiac disorders Atrioventricular block first degree	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Cardiac disorders Cardiac failure	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Cardiac disorders Extrasystoles	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Cardiac disorders Tachycardia	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Skin and subcutaneous tissue disorders Erythema	22.2% 2/9 • Number of events 2 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Infections and infestations Abscess limb	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Infections and infestations Urinary tract infection	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Injury, poisoning and procedural complications Foot fracture	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Injury, poisoning and procedural complications Urinary tract stoma complication	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Metabolism and nutrition disorders Abnormal weight gain	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Nervous system disorders Radiculopathy	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Renal and urinary disorders Nocturia	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Renal and urinary disorders Renal impairment	11.1% 1/9 • Number of events 1 • Until 30 days after last injection of study drug	0.00% 0/41 • Until 30 days after last injection of study drug
Gastrointestinal disorders Ileus	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug
Surgical and medical procedures Nephrostomy	0.00% 0/9 • Until 30 days after last injection of study drug	2.4% 1/41 • Number of events 1 • Until 30 days after last injection of study drug

Additional Information

Carol MacLean

Antev Ltd

Phone: +447525177617

Email: cmaclean@antev.co.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60