Trial Outcomes & Findings for The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC (NCT NCT03899467)

Last Updated: 2024-02-12

Results Overview

To evaluate the safety and tolerability of GT0918 assessed by AEs, SAEs between 400 mg arm vs. 500 mg arm with mHSPC or mCRPC who failed either abiraterone or enzalutamide treatment The percetage of AE and SAE would be evaluated in subjects with mHSPC and to determine the recommended Phase II dose (RP2D) over 6 months or longer treatment

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

Average of 24 weeks, up to a maximum of 30 weeks

Results posted on

2024-02-12

Participant Flow

The anticipated 60 subjects would be enrolled per protocol; Actually, total 61 subjects were randomized to take 400 mg or 500 mg of GT0918.

The anticipated 60 subjects would be enrolled per protocol; Actually, total 61 subjects were randomized to take 400 mg or 500 mg of GT0918; 31patients were enrolled in 400mg arm and 30 patiens were enrolled in 500mg arm respectively. Randomization of subjects were stratified by prior therapy (abiraterone or enzalutamide).The post enzalutamide and post abiraterone groups were not pre-specified to be analyzed and as separate Arms/Groups.

Participant milestones

Participant milestones
Measure	Arm 1: 400 mg /Day of GT0918 Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity	Arm 2: 500 mg/Day of GT0918 Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity
Overall Study STARTED	31	30
Overall Study COMPLETED	19	22
Overall Study NOT COMPLETED	12	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: 400 mg /Day of GT0918 n=31 Participants Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity	Arm 2: 500 mg/Day of GT0918 n=30 Participants Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity	Total n=61 Participants Total of all reporting groups
Age, Continuous	72.8 years STANDARD_DEVIATION 8.71 • n=5 Participants	74.3 years STANDARD_DEVIATION 7.39 • n=7 Participants	73.5 years STANDARD_DEVIATION 8.06 • 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	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
BMI	29.4 Kg/mg^2 n=5 Participants	29.1 Kg/mg^2 n=7 Participants	29.3 Kg/mg^2 n=5 Participants

PRIMARY outcome

Timeframe: Average of 24 weeks, up to a maximum of 30 weeks

Population: The Safety Analysis Set (SS) included all 61 subjects who have taken at least one dose of study medication;31 subjects and 30 subjects were incuded in 400mg daily arm and 500mg daily arm,respevtively

Outcome measures

Outcome measures
Measure	Arm 1: 400 mg /Day of GT0918 n=31 Participants Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity	Arm 2: 500 mg/Day of GT0918 n=30 Participants Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity
Evaluate the Safety and Tolerability of GT0918 and Select the RP2D for Future Clinical Trial Study. TEAE	28 Participants	29 Participants
Evaluate the Safety and Tolerability of GT0918 and Select the RP2D for Future Clinical Trial Study. SAE	6 Participants	12 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: The Full Analysis Set (FAS) will include subjects who have post-baseline PSA assessment.

The percentage of subjects achieving a ≥50% reduction in PSA at 3 months (12 weeks) as compared to baseline (study entry) was determined.

Outcome measures

Outcome measures
Measure	Arm 1: 400 mg /Day of GT0918 n=22 Participants Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity	Arm 2: 500 mg/Day of GT0918 n=18 Participants Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity
The Percentage of Subjects Achieving a ≥50% Reduction in PSA at 12 Weeks and 24 Weeks PSA ≥50% reduction at Week 12	2 Participants	1 Participants
The Percentage of Subjects Achieving a ≥50% Reduction in PSA at 12 Weeks and 24 Weeks PSA ≥50% reduction at Week 24	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: The Full Analysis Set (FAS) will include subjects who have at least one post-treatment tumor assessment.

Time to PSA Progression in 400mg group and 500mg group

Outcome measures

Outcome measures
Measure	Arm 1: 400 mg /Day of GT0918 n=22 Participants Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity	Arm 2: 500 mg/Day of GT0918 n=18 Participants Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity
Time to PSA Progression	85 day Interval 29.0 to 168.0	83.5 day Interval 27.0 to 168.0

SECONDARY outcome

Timeframe: 24 weeks

Population: The percentage change of PSA from baseline at any visit was calculated for the FAS

The percentage of change of PSA from baseline at Week 12 was calculated. Maximum percentage change of PSA from baseline at any time was calculated.

Outcome measures

Outcome measures
Measure	Arm 1: 400 mg /Day of GT0918 n=29 Participants Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity	Arm 2: 500 mg/Day of GT0918 n=29 Participants Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity
PSA Maximum Change at 12 Weeks	-5.58 percent change Interval -99.1 to 25948.6	45.61 percent change Interval -97.3 to 470.3

Adverse Events

Arm 1: 400 mg /Day of GT0918

Serious events: 6 serious events

Other events: 28 other events

Deaths: 0 deaths

Arm 2: 500 mg/Day of GT0918

Serious events: 12 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Millie Gu

Suzhou Kintor Pharmaceuticals,Inc.

Phone: +8651262639938

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Arm 1: 400 mg /Day of GT0918 n=31 participants at risk Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity	Arm 2: 500 mg/Day of GT0918 n=30 participants at risk Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity
Musculoskeletal and connective tissue disorders Rhabdomyolysis	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Nervous system disorders Metabolic encephalopathy	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Cardiac disorders Atrial fibrillation	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	6.7% 2/30 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Eye disorders Visual impairment	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Investigations Alanine aminotransferase increased	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Investigations Aspartate aminotransferase increased	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	6.7% 2/30 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	6.7% 2/30 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Blood and lymphatic system disorders Anemia	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Blood and lymphatic system disorders Neutropenia	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Cardiac disorders Cardiac failure congestive	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Infections and infestations Diverticulitis	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Infections and infestations Neutropenic sepsis	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Infections and infestations Pneumonia	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Investigations Hepatic enzyme increased	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Psychiatric disorders Suicide attempt	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Vascular disorders Hypotension	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Respiratory, thoracic and mediastinal disorders Pneumothorax	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Gastrointestinal disorders Gastrointestinal haemorrhage	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Infections and infestations Skin infection	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Vascular disorders Dry gangrene	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Respiratory, thoracic and mediastinal disorders COVID-19 pneumonia	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.

Other adverse events
Measure	Arm 1: 400 mg /Day of GT0918 n=31 participants at risk Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity	Arm 2: 500 mg/Day of GT0918 n=30 participants at risk Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity
Gastrointestinal disorders Constipation	35.5% 11/31 • Number of events 11 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	43.3% 13/30 • Number of events 13 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Gastrointestinal disorders Diarrhoea	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	13.3% 4/30 • Number of events 4 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Gastrointestinal disorders Nausea	25.8% 8/31 • Number of events 8 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	23.3% 7/30 • Number of events 7 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
General disorders Fatigue	48.4% 15/31 • Number of events 15 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	53.3% 16/30 • Number of events 16 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
General disorders Asthenia	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	13.3% 4/30 • Number of events 4 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
General disorders Oedema peripheral	25.8% 8/31 • Number of events 8 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	23.3% 7/30 • Number of events 7 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Injury, poisoning and procedural complications Fall	12.9% 4/31 • Number of events 4 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	23.3% 7/30 • Number of events 7 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Investigations Weight decreased	16.1% 5/31 • Number of events 5 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	33.3% 10/30 • Number of events 10 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Metabolism and nutrition disorders Decreased appetite	29.0% 9/31 • Number of events 9 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	46.7% 14/30 • Number of events 14 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Musculoskeletal and connective tissue disorders Muscular weakness	22.6% 7/31 • Number of events 7 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	10.0% 3/30 • Number of events 3 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Nervous system disorders Dizziness	12.9% 4/31 • Number of events 4 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	6.7% 2/30 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Nervous system disorders Dysgeusia	12.9% 4/31 • Number of events 4 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	6.7% 2/30 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Nervous system disorders Headache	12.9% 4/31 • Number of events 4 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	10.0% 3/30 • Number of events 3 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Psychiatric disorders Depression	12.9% 4/31 • Number of events 4 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Vascular disorders Hot flush	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	13.3% 4/30 • Number of events 4 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Blood and lymphatic system disorders Anaemia	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	10.0% 3/30 • Number of events 3 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Musculoskeletal and connective tissue disorders Back pain	12.9% 4/31 • Number of events 4 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Renal and urinary disorders Haematuria	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	10.0% 3/30 • Number of events 3 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Respiratory, thoracic and mediastinal disorders Dyspnoea	22.6% 7/31 • Number of events 7 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	10.0% 3/30 • Number of events 3 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Ear and labyrinth disorders Vertigo	0.00% 0/31 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	6.7% 2/30 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Eye disorders Vision blurred	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	6.7% 2/30 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Gastrointestinal disorders Abdominal pain	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Gastrointestinal disorders Vomiting	9.7% 3/31 • Number of events 3 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	10.0% 3/30 • Number of events 3 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
General disorders Gait disturbance	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Infections and infestations Urinary tract infection	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Injury, poisoning and procedural complications Skin abrasion	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Investigations Blood alkaline phosphatase increased	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Investigations Blood lactate dehydrogenase increased	9.7% 3/31 • Number of events 3 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Metabolism and nutrition disorders Dehydration	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Metabolism and nutrition disorders Hypoglycaemia	3.2% 1/31 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	6.7% 2/30 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Metabolism and nutrition disorders Hypokalaemia	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	6.7% 2/30 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Musculoskeletal and connective tissue disorders Pain in extremity	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Nervous system disorders Hypersomnia	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	0.00% 0/30 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Nervous system disorders Memory impairment	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	3.3% 1/30 • Number of events 1 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Psychiatric disorders Confusional state	9.7% 3/31 • Number of events 3 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	6.7% 2/30 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Psychiatric disorders Insomnia	9.7% 3/31 • Number of events 3 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	6.7% 2/30 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Respiratory, thoracic and mediastinal disorders Hiccups	6.5% 2/31 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.	6.7% 2/30 • Number of events 2 • Average of 24 weeks, up to a maximum of 30 weeks An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.