Trial Outcomes & Findings for A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection (NCT NCT05137717)

NCT ID: NCT05137717

Last Updated: 2024-07-09

Results Overview

The confirmed viremia clearance was defined as a plasma CMV DNA concentration below the lower limit of quantification (LLOQ) (that is \[i.e.\], less than \[\<\] 34.5 international units per milliliter \[IU/mL\]) when assessed by the COBAS® 8800/COBAS® CMV Test, in two consecutive post-baseline samples, separated by at least 5 days. To be considered a responder for the primary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 41 participants
• Primary outcome timeframe: At Week 8
• Results posted on: 2024-07-09

Participant Flow

The study was conducted at 23 sites in Japan from 18 January 2022 to 27 June 2023.

Japanese participants with cytomegalovirus (CMV) infection were enrolled to receive maribavir treatment in this study.

Participant milestones

Measure	Maribavir Participants received maribavir 400 milligrams (mg), oral tablet, twice a day (BID) for up to 8 weeks.
Overall Study STARTED	41
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Maribavir Participants received maribavir 400 milligrams (mg), oral tablet, twice a day (BID) for up to 8 weeks.
Overall Study Death	2
Overall Study Withdrawal by Subject	6

Baseline Characteristics

A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection

Baseline characteristics by cohort

Measure	Maribavir n=41 Participants Participants received maribavir 400 milligrams (mg), oral tablet, twice a day (BID) for up to 8 weeks.
Age, Continuous	53.9 years STANDARD_DEVIATION 11.16 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	41 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Japan	41 Participants n=5 Participants
Height	164.46 centimetres (cm) STANDARD_DEVIATION 8.702 • n=5 Participants
Weight	57.47 kilograms (kg) STANDARD_DEVIATION 10.707 • n=5 Participants
Body Mass Index (BMI)	21.26 kilograms per meter square (kg/m^2) STANDARD_DEVIATION 3.538 • n=5 Participants

PRIMARY outcome

Timeframe: At Week 8

Population: FAS included of all participants who had taken at least 1 dose of study treatment.

The confirmed viremia clearance was defined as a plasma CMV DNA concentration below the lower limit of quantification (LLOQ) (that is [i.e.], less than [<] 34.5 international units per milliliter [IU/mL]) when assessed by the COBAS® 8800/COBAS® CMV Test, in two consecutive post-baseline samples, separated by at least 5 days. To be considered a responder for the primary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed).

Outcome measures

Measure	Maribavir n=41 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) at Week 8	68.3 percentage of participants Interval 51.9 to 81.9

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 20

Population: Safety set included of all participants who had taken at least 1 dose of study treatment.

A TEAEs was defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the investigational product or medicinal product. An SAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability / incapacity, was a congenital anomaly / birth defect or was medically important due to other reasons than the above mentioned criteria.

Outcome measures

Measure	Maribavir n=41 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs Participants with TEAEs	39 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs Participants with Serious TEAEs	13 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 20

Population: Safety set included of all participants who had taken at least 1 dose of study treatment.

The number of participants with TEAEs leading to maribavir study treatment discontinuation (including treatment interruption or withdrawal) were reported.

Outcome measures

Measure	Maribavir n=41 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Number of Participants With TEAEs Leading to Treatment Discontinuation With Maribavir	9 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 20

Population: Safety set included of all participants who had taken at least 1 dose of study treatment.

Vital sign assessments included blood pressure, pulse, respiratory rate and body temperature. Any clinically meaningful change in vital signs which were deemed clinically significant by the investigator were reported.

Outcome measures

Measure	Maribavir n=41 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Number of Participants With Clinically Meaningful Changes in Vital Signs	0 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 20

Population: Safety set included of all participants who had taken at least 1 dose of study treatment.

Physical examination included assessments of the head, eyes, ears, nose, throat, neck, lymph nodes, and the cardiovascular, dermatological, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurological systems. Any clinically meaningful change in physical examination which were deemed clinically significant by the investigator were reported.

Outcome measures

Measure	Maribavir n=41 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Number of Participants With Clinically Meaningful Abnormalities in Physical Examination Findings	0 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 20

Population: Safety set included of all participants who had taken at least 1 dose of study treatment.

Clinical laboratory parameters included evaluations of hematology, chemistry, urinalysis. Any clinically meaningful change in clinical laboratory parameters which were deemed clinically significant by the investigator were reported.

Outcome measures

Measure	Maribavir n=41 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Number of Participants With Clinically Meaningful Abnormalities in Clinical Laboratory Parameters	0 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 20

Population: Safety set included of all participants who had taken at least 1 dose of study treatment.

12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically meaningful by the investigator were reported.

Outcome measures

Measure	Maribavir n=41 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Number of Participants With Clinically Meaningful Changes in Electrocardiograms (ECGs)	0 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 8

Population: Safety set included of all participants who had taken at least 1 dose of study treatment.

Immunosuppressant drug concentration testing was solely for participants who received immunosuppressive therapy with tacrolimus, cyclosporine, or everolimus. The number of participants with an increased level of at least one immunosuppressant drug was reported.

Outcome measures

Measure	Maribavir n=41 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Number of Participants With Events of Immunosuppressant Drug Level Increased in Blood	1 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 20

Population: Safety set included of all participants who had taken at least 1 dose of study treatment.

New onset of acute or chronic GVHD assessed as TEAEs, and graft rejection, or graft loss assessed were reported.

Outcome measures

Measure	Maribavir n=41 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Number of Participants With TEAEs of New Onset of Acute or Chronic Graft-versus-host Disease (GVHD), Graft Rejection, or Graft Loss TEAEs of Acute or Chronic GVHD	2 Participants
Number of Participants With TEAEs of New Onset of Acute or Chronic Graft-versus-host Disease (GVHD), Graft Rejection, or Graft Loss TEAEs of Graft Rejection, or Graft Loss	0 Participants

SECONDARY outcome

Timeframe: At Week 8 through Weeks 12, 16 and 20

Population: FAS included of all participants who had taken at least 1 dose of study treatment.

The confirmed viremia clearance was defined as a plasma CMV DNA concentration below the LLOQ (i.e., <34.5 IU/mL) when assessed by the COBAS® 8800/COBAS® CMV Test, in two consecutive post-baseline samples, separated by at least 5 days. Percentage of participants who maintained combined CMV viremia clearance and CMV infection symptom control at Week 8 Through Weeks 12, 16 and 20 were reported.

Outcome measures

Measure	Maribavir n=41 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 Through Weeks 12, 16 and 20 At Week 8	68.3 percentage of participants Interval 51.9 to 81.9
Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 Through Weeks 12, 16 and 20 At Week 12	34.1 percentage of participants Interval 20.1 to 50.6
Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 Through Weeks 12, 16 and 20 At Week 16	29.3 percentage of participants Interval 16.1 to 45.5
Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 Through Weeks 12, 16 and 20 At Week 20	26.8 percentage of participants Interval 14.2 to 42.9

SECONDARY outcome

Timeframe: From first dose of study drug up to Week 20

Population: FAS included of all participants who had taken at least 1 dose of study treatment.

Time to first confirmed viremia clearance was defined as time from the start date of first dose of study treatment to the date of confirmed viremia clearance (event), or the date of last CMV DNA assessment on study before the initiation of alternative anti-CMV treatment (censored). The time to first confirmed CMV viremia clearance was calculated as date of first confirmed CMV viremia clearance - randomization date + 1). The date of first confirmed CMV viremia clearance was the date of first of two consecutive samples with plasma CMV DNA <LLOQ that meet the criteria of confirmed CMV viremia clearance.

Outcome measures

Measure	Maribavir n=41 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Time to First Confirmed CMV Viremia Clearance	22.0 days Interval 15.0 to 23.0

SECONDARY outcome

Timeframe: From Week 9 up to Week 20

Population: FAS included of all participants who had taken at least 1 dose of study treatment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Recurrence of confirmed CMV viremia was defined as plasma CMV DNA concentration greater than or equal to (>= 34.5 IU/mL) LLOQ when assessed by the COBAS® 8800/COBAS®CMV Test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance.

Outcome measures

Measure	Maribavir n=28 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Percentage of Participants With Recurrence of Confirmed CMV Viremia During Follow-up Period in Participants With Confirmed Viremia Clearance at Week 8 Who Required Additional Anti-CMV Treatment	42.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12, 14, 16, 18 and 20

Population: FAS included of all participants who had taken at least 1 dose of study treatment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for the specified timepoints.

The change from baseline in plasma CMV viral load, i.e., plasma CMV DNA concentration was assessed and reported.

Outcome measures

Measure	Maribavir n=38 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Change From Baseline in Plasma CMV Viremia Load Change at Week 1	-0.7821 IU/mL Standard Deviation 0.62350
Change From Baseline in Plasma CMV Viremia Load Change at Week 2	-1.4813 IU/mL Standard Deviation 0.71540
Change From Baseline in Plasma CMV Viremia Load Change at Week 3	-1.7935 IU/mL Standard Deviation 0.86625
Change From Baseline in Plasma CMV Viremia Load Change at Week 4	-1.9555 IU/mL Standard Deviation 0.90538
Change From Baseline in Plasma CMV Viremia Load Change at Week 5	-2.0383 IU/mL Standard Deviation 0.97092
Change From Baseline in Plasma CMV Viremia Load Change at Week 6	-1.9922 IU/mL Standard Deviation 1.02593
Change From Baseline in Plasma CMV Viremia Load Change at Week 7	-1.9718 IU/mL Standard Deviation 1.10335
Change From Baseline in Plasma CMV Viremia Load Change at Week 8	-1.7971 IU/mL Standard Deviation 1.28349
Change From Baseline in Plasma CMV Viremia Load Change at Week 9	-1.7771 IU/mL Standard Deviation 0.92825
Change From Baseline in Plasma CMV Viremia Load Change at Week 10	-1.6819 IU/mL Standard Deviation 0.93517
Change From Baseline in Plasma CMV Viremia Load Change at Week 11	-1.5275 IU/mL Standard Deviation 0.94430
Change From Baseline in Plasma CMV Viremia Load Change at Week 12	-1.5383 IU/mL Standard Deviation 1.07532
Change From Baseline in Plasma CMV Viremia Load Change at Week 14	-1.7712 IU/mL Standard Deviation 1.08735
Change From Baseline in Plasma CMV Viremia Load Change at Week 16	-1.7042 IU/mL Standard Deviation 1.05775
Change From Baseline in Plasma CMV Viremia Load Change at Week 18	-1.9569 IU/mL Standard Deviation 0.83577
Change From Baseline in Plasma CMV Viremia Load Change at Week 20	-1.9734 IU/mL Standard Deviation 0.91902

SECONDARY outcome

Timeframe: Study treatment: Week 0 to Week 8; Follow-up Period:Week 9 to Week 20; At Any time during study:Week 0 to Week 20; While on study assigned treatment: Week 0 to EOT(Week 8 or earlier); While off study assigned treatment: EOT (Week 8 or earlier) to Week 20

Population: FAS included of all participants who had taken at least 1 dose of study treatment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Recurrence of CMV viremia was defined as plasma CMV DNA concentration >= lower limit of quantification (LLOQ, i.e. >=34.5 IU/mL) when assessed by COBAS® 8800/COBAS® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (<LLOQ, i.e. <34.5 IU/mL) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study. Study Treatment: The first stipulated 8 weeks treatment. Follow up period: period started after completion of stipulated 8 weeks treatment to Week 20. While on study assigned treatment: period over which participants received actual dosing regardless of stipulated 8 weeks completion (Week 8 or earlier). While off study assigned treatment: period after study treatment, regardless of stipulated 8 weeks completion (Week 8 or earlier up to Week 20).

Outcome measures

Measure	Maribavir n=36 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Percentage of Participants With Recurrence of CMV Viremia During Study Treatment and in the Follow-Up Period After the Participants Are Discontinued From Study Treatment and While On/Off Study Assigned Treatment Study Treatment: (Week 0 to Week 8)	13.9 percentage of participants
Percentage of Participants With Recurrence of CMV Viremia During Study Treatment and in the Follow-Up Period After the Participants Are Discontinued From Study Treatment and While On/Off Study Assigned Treatment Follow-up Period: (Week 9 to Week 20)	44.4 percentage of participants
Percentage of Participants With Recurrence of CMV Viremia During Study Treatment and in the Follow-Up Period After the Participants Are Discontinued From Study Treatment and While On/Off Study Assigned Treatment At Any Time During the Study (Week 0 to Week 20)	58.3 percentage of participants
Percentage of Participants With Recurrence of CMV Viremia During Study Treatment and in the Follow-Up Period After the Participants Are Discontinued From Study Treatment and While On/Off Study Assigned Treatment While on Study Assigned Treatment (Week 0 to End of Treatment [EOT] [Week 8 or earlier])	8.3 percentage of participants
Percentage of Participants With Recurrence of CMV Viremia During Study Treatment and in the Follow-Up Period After the Participants Are Discontinued From Study Treatment and While On/Off Study Assigned Treatment While off Study Assigned Treatment (EOT [Week 8 or earlier] to Week 20)	50.0 percentage of participants

SECONDARY outcome

Timeframe: From first dose of study drug up to Week 20

Population: FAS included of all participants who had taken at least 1 dose of study treatment.

Plasma samples were obtained and tested to identify mutations in the viral UL97 and UL54 genes confer resistance to maribavir. Percentage of participants with any mutations in the CMV genes conferring resistance to maribavir was reported.

Outcome measures

Measure	Maribavir n=41 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Percentage of Participants With Any Mutations in the CMV Genes Conferring Resistance to Maribavir	12.2 percentage of participants

SECONDARY outcome

Timeframe: At Week 8

Population: FAS included of all participants who had taken at least 1 dose of study treatment.

The confirmed CMV viremia clearance at Week 8 was defined as plasma CMV DNA concentrations <137 IU/mL, in 2 consecutive post-baseline samples separated by at least 5 days, regardless of whether study treatment was discontinued before the end of the stipulated 8 weeks of therapy.

Outcome measures

Measure	Maribavir n=41 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance at Week 8 to be Less Than (<) 137 IU/mL	73.2 percentage of participants Interval 57.1 to 85.8

SECONDARY outcome

Timeframe: At Weeks 1, 4, and 8: Pre-dose

Population: Pharmacokinetic set included of all participants in the safety set who had plasma sample drawn and tested for maribavir concentrations. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for the specified timepoints.

Cmin (pre-dose) of maribavir was assessed.

Outcome measures

Measure	Maribavir n=36 Participants Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Minimum Observed Plasma Concentration (Cmin) of Maribavir Week 1: Pre-dose	10.08 micrograms per milliliter (mcg/mL) Geometric Coefficient of Variation 105.73
Minimum Observed Plasma Concentration (Cmin) of Maribavir Week 4: Pre-dose	12.31 micrograms per milliliter (mcg/mL) Geometric Coefficient of Variation 108.05
Minimum Observed Plasma Concentration (Cmin) of Maribavir Week 8: Pre-dose	12.37 micrograms per milliliter (mcg/mL) Geometric Coefficient of Variation 95.26

Adverse Events

Maribavir

Serious events: 13 serious events

Other events: 26 other events

Deaths: 2 deaths

Serious adverse events

Measure	Maribavir n=41 participants at risk Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Infections and infestations COVID-19	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Infections and infestations COVID-19 pneumonia	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Cardiac disorders Cardiac failure	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia recurrent	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Infections and infestations Cytomegalovirus chorioretinitis	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Infections and infestations Cytomegalovirus enterocolitis	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Blood and lymphatic system disorders Febrile neutropenia	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Immune system disorders Graft versus host disease	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Immune system disorders Graft versus host disease in gastrointestinal tract	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Hepatobiliary disorders Hyperbilirubinaemia	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal pain	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Gastrointestinal disorders Melaena	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Blood and lymphatic system disorders Neutropenia	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Infections and infestations Pneumonia legionella	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
General disorders Pyrexia	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Infections and infestations Septic shock	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Infections and infestations Sinusitis	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Injury, poisoning and procedural complications Transplantation complication	2.4% 1/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.

Other adverse events

Measure	Maribavir n=41 participants at risk Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks.
Blood and lymphatic system disorders Anaemia	17.1% 7/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	9.8% 4/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Nervous system disorders Dysgeusia	7.3% 3/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
General disorders Generalised oedema	9.8% 4/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Nervous system disorders Headache	14.6% 6/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Vascular disorders Hypertension	7.3% 3/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Psychiatric disorders Insomnia	9.8% 4/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Gastrointestinal disorders Nausea	24.4% 10/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Investigations Neutrophil count decreased	7.3% 3/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
General disorders Oedema peripheral	7.3% 3/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
General disorders Pyrexia	14.6% 6/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.
Nervous system disorders Taste disorder	9.8% 4/41 • From the first dose of study drug up to Week 20 Safety set included of all participants who had taken at least 1 dose of study treatment.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: TrialDisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
• Publication restrictions are in place

Restriction type: OTHER