Trial Outcomes & Findings for A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402) (NCT NCT01294800)

Last Updated: 2018-11-08

Results Overview

The "on" state is defined as the period of time during which a participant's symptoms of PD improve or disappear following treatment with levodopa (L-dopa) or dopamine agonists. The "off" state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as "off", "on", or "asleep" on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in "off" time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects, and an unstructured covariance matrix was used to model the correlation among repeated measurements.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

450 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2018-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Preladenant 2 mg Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 5 mg Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 10 mg Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Placebo Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
Overall Study STARTED	111	113	113	113
Overall Study COMPLETED	100	103	96	97
Overall Study NOT COMPLETED	11	10	17	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Preladenant 2 mg Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 5 mg Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 10 mg Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Placebo Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
Overall Study Adverse Event	7	6	12	5
Overall Study Subject Withdrew Consent	2	2	2	11
Overall Study Lost to Follow-up	0	0	1	0
Overall Study Non-compliance With Protocol	0	1	1	0
Overall Study Did Not Meet Protocol Eligibility	2	1	1	0

Baseline Characteristics

A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preladenant 2 mg n=111 Participants Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 5 mg n=113 Participants Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 10 mg n=113 Participants Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Placebo n=113 Participants Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Total n=450 Participants Total of all reporting groups
Age, Continuous	68.0 Years STANDARD_DEVIATION 7.9 • n=93 Participants	67.6 Years STANDARD_DEVIATION 8.3 • n=4 Participants	67.8 Years STANDARD_DEVIATION 7.6 • n=27 Participants	65.8 Years STANDARD_DEVIATION 9.1 • n=483 Participants	67.3 Years STANDARD_DEVIATION 8.3 • n=36 Participants
Sex: Female, Male Female	54 Participants n=93 Participants	66 Participants n=4 Participants	69 Participants n=27 Participants	64 Participants n=483 Participants	253 Participants n=36 Participants
Sex: Female, Male Male	57 Participants n=93 Participants	47 Participants n=4 Participants	44 Participants n=27 Participants	49 Participants n=483 Participants	197 Participants n=36 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.

Outcome measures

Outcome measures
Measure	Preladenant 2 mg n=98 Participants Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 5 mg n=101 Participants Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 10 mg n=93 Participants Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Placebo n=90 Participants Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
Change From Baseline in Mean "Off" Time (Hours Per Day) at Week 12	-1.2 Hours/Day Standard Deviation 2.3	-1.0 Hours/Day Standard Deviation 2.6	-0.9 Hours/Day Standard Deviation 2.2	-0.5 Hours/Day Standard Deviation 3.0

PRIMARY outcome

Timeframe: Up to 14 weeks

Population: All Participants as Treated population, which included all participants who received at least one dose of study drug

An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.

Outcome measures

Outcome measures
Measure	Preladenant 2 mg n=111 Participants Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 5 mg n=113 Participants Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 10 mg n=113 Participants Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Placebo n=113 Participants Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
Number of Participants Who Experienced an Adverse Event (AE)	53 Participants	60 Participants	69 Participants	55 Participants

PRIMARY outcome

Timeframe: Up to 12 Weeks

Population: All Participants as Treated population, which included all participants who received at least one dose of study drug

Outcome measures

Outcome measures
Measure	Preladenant 2 mg n=111 Participants Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 5 mg n=113 Participants Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 10 mg n=113 Participants Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Placebo n=113 Participants Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
Number of Participants Who Discontinued Study Treatment Due to an AE	6 Participants	6 Participants	12 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 12 Weeks

The proportion of responders (≥30% Reduction in "Off" Time at Week 12) was analyzed using a generalized linear mixed model with baseline mean OFF time (hours/day) as a covariate and treatment-by-time interaction as a fixed effect, and an unstructured covariance matrix was used to model the correlation among repeated measurements. Responder rates for each treatment arm are presented as are differences from placebo with 95% confidence interval.

Outcome measures

Outcome measures
Measure	Preladenant 2 mg n=110 Participants Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 5 mg n=113 Participants Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 10 mg n=110 Participants Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Placebo n=112 Participants Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
Percentage of Participants With ≥30% Reduction in "Off" Time at Week 12	34.5 Percentage of participants	34.6 Percentage of participants	24.6 Percentage of participants	28.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.

When a participant is "on" without dyskinesias, parkinsonian symptoms have dissipated and the participant is experiencing no uncontrollable extraneous movements. Study participants reported their parkinsonian symptoms at half-hour intervals as "off", "on without dyskinesia", "on with non-troublesome dyskinesia", "on with troublesome dyskinesia", or "asleep" on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit. The mean change from baseline in "on without troublesome dyskinesia" time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects, and an unstructured covariance matrix was used to model the correlation among repeated measurements.

Outcome measures

Outcome measures
Measure	Preladenant 2 mg n=98 Participants Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 5 mg n=101 Participants Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 10 mg n=93 Participants Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Placebo n=90 Participants Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
Change From Baseline in Mean "On" Time Without Troublesome Dyskinesias (Hours Per Day) at Week 12	1.3 Hours/Day Standard Deviation 2.5	1.0 Hours/Day Standard Deviation 2.9	1.0 Hours/Day Standard Deviation 2.4	0.5 Hours/Day Standard Deviation 2.9

Adverse Events

Preladenant 2 mg

Serious events: 9 serious events

Other events: 19 other events

Deaths: 0 deaths

Preladenant 5 mg

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

Preladenant 10 mg

Serious events: 7 serious events

Other events: 25 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Preladenant 2 mg n=111 participants at risk Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 5 mg n=113 participants at risk Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 10 mg n=113 participants at risk Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Placebo n=113 participants at risk Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
Gastrointestinal disorders CONSTIPATION	2.7% 3/111 • Number of events 3 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	4.4% 5/113 • Number of events 5 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	7.1% 8/113 • Number of events 8 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	3.5% 4/113 • Number of events 4 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Infections and infestations NASOPHARYNGITIS	4.5% 5/111 • Number of events 5 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	8.0% 9/113 • Number of events 11 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	7.1% 8/113 • Number of events 8 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	7.1% 8/113 • Number of events 10 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Injury, poisoning and procedural complications FALL	7.2% 8/111 • Number of events 10 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	2.7% 3/113 • Number of events 3 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	6.2% 7/113 • Number of events 8 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Nervous system disorders DYSKINESIA	2.7% 3/111 • Number of events 3 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	6.2% 7/113 • Number of events 7 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	6.2% 7/113 • Number of events 7 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	1.8% 2/113 • Number of events 2 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc) that report any results of the trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Preladenant 2 mg n=111 participants at risk Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 5 mg n=113 participants at risk Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Preladenant 10 mg n=113 participants at risk Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.	Placebo n=113 participants at risk Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/111 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.88% 1/113 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Gastrointestinal disorders INGUINAL HERNIA	0.90% 1/111 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.88% 1/113 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Gastrointestinal disorders LARGE INTESTINE POLYP	0.00% 0/111 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.88% 1/113 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Gastrointestinal disorders LOWER GASTROINTESTINAL HAEMORRHAGE	0.90% 1/111 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
General disorders GAIT DISTURBANCE	0.00% 0/111 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.88% 1/113 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.88% 1/113 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Hepatobiliary disorders DRUG-INDUCED LIVER INJURY	0.00% 0/111 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.88% 1/113 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Infections and infestations CELLULITIS	0.00% 0/111 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.88% 1/113 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Infections and infestations PNEUMONIA	0.90% 1/111 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/111 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.88% 1/113 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Injury, poisoning and procedural complications HEAT STROKE	0.90% 1/111 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.90% 1/111 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Injury, poisoning and procedural complications ULNA FRACTURE	0.00% 0/111 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.88% 1/113 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Musculoskeletal and connective tissue disorders JAW CYST	0.90% 1/111 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/111 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.88% 1/113 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.00% 0/111 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	1.8% 2/113 • Number of events 2 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO LYMPH NODES	0.00% 0/111 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.88% 1/113 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Nervous system disorders PARKINSON'S DISEASE	1.8% 2/111 • Number of events 2 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	1.8% 2/113 • Number of events 2 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Psychiatric disorders IMPULSE-CONTROL DISORDER	0.00% 0/111 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.88% 1/113 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Renal and urinary disorders CYSTITIS HAEMORRHAGIC	0.00% 0/111 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.88% 1/113 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Renal and urinary disorders URINARY RETENTION	0.90% 1/111 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug
Social circumstances ACTIVITIES OF DAILY LIVING IMPAIRED	0.00% 0/111 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.88% 1/113 • Number of events 1 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug	0.00% 0/113 • Up to 14 weeks All Participants as Treated population, which included all participants who received at least one dose of study drug