Trial Outcomes & Findings for A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients (NCT NCT00090766)

NCT ID: NCT00090766

Last Updated: 2016-10-31

Results Overview

Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24 hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to measure the plasma concentrations of valganciclovir. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 63 participants
• Primary outcome timeframe: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14
• Results posted on: 2016-10-31

Participant Flow

A total of 63 participants were enrolled in this study conducted from 28 May 2004 to 13 May 2005. The study was conducted at 18 centers in 7 countries.

Participants were screened within 48 hours prior to transplant surgery (Day 1) and received valganciclovir from Day 1.

Participant milestones

Measure	Valganciclovir Age Group <= 2 Years Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* body surface area \[BSA\] \* creatinine clearance \[CrCLS\]).	Valganciclovir Age Group >2 to < 12 Years Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Overall Study STARTED	17	21	25
Overall Study COMPLETED	14	19	22
Overall Study NOT COMPLETED	3	2	3

Reasons for withdrawal

Measure	Valganciclovir Age Group <= 2 Years Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* body surface area \[BSA\] \* creatinine clearance \[CrCLS\]).	Valganciclovir Age Group >2 to < 12 Years Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Overall Study Nephrectomy Planned	0	0	1
Overall Study Death	1	0	0
Overall Study Admin	0	2	0
Overall Study Lost to Follow-up	2	0	2

Baseline Characteristics

A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients

Baseline characteristics by cohort

Measure	Valganciclovir Age Group <= 2 Years n=17 Participants Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years n=21 Participants Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years n=25 Participants Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Total n=63 Participants Total of all reporting groups
Age, Continuous	0.6 years STANDARD_DEVIATION 0.86 • n=5 Participants	6.9 years STANDARD_DEVIATION 3.15 • n=7 Participants	14.2 years STANDARD_DEVIATION 1.54 • n=5 Participants	8.1 years STANDARD_DEVIATION 5.94 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	34 Participants n=4 Participants

PRIMARY outcome

Timeframe: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14

Population: Pharmacokinetic (PK) population comprised of all participants from studies WP16296, WP16303 and WV16726 who had completed the specified treatment and from whom at least one plasma sample was taken. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.

Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24 hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to measure the plasma concentrations of valganciclovir. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.

Outcome measures

Measure	Valganciclovir Age Group <= 2 Years n=17 Participants Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years n=20 Participants Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years n=25 Participants Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir In liver recipients, n=9, 6, 2	69.4 mcg*hr/mL Standard Deviation 35.4	58.4 mcg*hr/mL Standard Deviation 6.18	35.6 mcg*hr/mL Standard Deviation 2.76
Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir In kidney recipients, n=2, 12, 19	65.2 mcg*hr/mL Standard Deviation 16.6	55 mcg*hr/mL Standard Deviation 11.9	50 mcg*hr/mL Standard Deviation 11.6
Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir In heart recipients, n=6, 2, 4	56.3 mcg*hr/mL Standard Deviation 23.2	60 mcg*hr/mL Standard Deviation 19.3	61.2 mcg*hr/mL Standard Deviation 26

PRIMARY outcome

Timeframe: Up to Week 26

Population: Safety population included all participants who received at least one dose of valganciclovir.

An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported.

Outcome measures

Measure	Valganciclovir Age Group <= 2 Years n=17 Participants Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years n=21 Participants Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years n=25 Participants Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Number of Participants With Adverse Events Leading to Dose Interruption or Modification	4 participants	2 participants	3 participants

PRIMARY outcome

Timeframe: Up to Week 26

Population: Safety population included all participants who received at least one dose of valganciclovir.

Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported.

Outcome measures

Measure	Valganciclovir Age Group <= 2 Years n=17 Participants Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years n=21 Participants Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years n=25 Participants Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Number of Participants With Opportunistic Infections Oral Candidiasis	2 participants	0 participants	0 participants
Number of Participants With Opportunistic Infections Candidiasis	1 participants	0 participants	0 participants
Number of Participants With Opportunistic Infections Herpes Simplex	0 participants	1 participants	0 participants
Number of Participants With Opportunistic Infections Cytomegalovirus Antigen Positive	1 participants	0 participants	0 participants
Number of Participants With Opportunistic Infections Cytomegalovirus Test Positive	1 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Up to Week 26

Population: Safety population included all participants who received at least one dose of valganciclovir.

An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any experience or a significant hazard, that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing one, results in persistent or significant disability, is a congenital anomaly, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

Outcome measures

Measure	Valganciclovir Age Group <= 2 Years n=17 Participants Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years n=21 Participants Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years n=25 Participants Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Number of Participants With Any Adverse Events and Any Serious Adverse Events Any AE	17 participants	18 participants	24 participants
Number of Participants With Any Adverse Events and Any Serious Adverse Events Any SAE	13 participants	11 participants	11 participants

PRIMARY outcome

Timeframe: Up to Week 26

Population: Safety population included all participants who received at least one dose of valganciclovir.

An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to discontinuation of the study drug is reported.

Outcome measures

Measure	Valganciclovir Age Group <= 2 Years n=17 Participants Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years n=21 Participants Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years n=25 Participants Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug	1 participants	2 participants	0 participants

PRIMARY outcome

Timeframe: Up to Week 26

Population: Safety population included all participants who received at least one dose of valganciclovir.

The number of participants experiencing a 3 grade shift (example from Grade 0 to Grade 3) from baseline (BL) in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.

Outcome measures

Measure	Valganciclovir Age Group <= 2 Years n=63 Participants Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Hemoglobin low, n= 63	6 participants	—	—
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry White blood cell count low, n= 59	3 participants	—	—
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Lymphocytes low, n= 54	3 participants	—	—
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Neutrophils low, n= 54	7 participants	—	—
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Potassium low, n=56	4 participants	—	—
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Potassium high, n=57	4 participants	—	—
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Alkaline Phosphatase high, n=40	1 participants	—	—
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Alanine transaminase high, n=48	1 participants	—	—
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Total Bilirubin high, n=38	1 participants	—	—
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Sodium low, n=58	2 participants	—	—
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Sodium high, n=57	0 participants	—	—
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Calcium low, n=46	1 participants	—	—
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Phosphate low, n=43	2 participants	—	—
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Fasting Glucose low, n=39	1 participants	—	—
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Uric Acid high, n=21	2 participants	—	—

PRIMARY outcome

Timeframe: Up to Week 26

Population: Safety population included all participants who received at least one dose of valganciclovir.

The number of participants experiencing a 4 grade shift (example from Grade 0 to Grade 4) from BL in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.

Outcome measures

Measure	Valganciclovir Age Group <= 2 Years n=63 Participants Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry White blood cell count low, n= 59	1 participants	—	—
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Lymphocytes low, n= 54	3 participants	—	—
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Neutrophils low, n= 54	4 participants	—	—
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Potassium low, n=56	0 participants	—	—
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Potassium high, n=57	2 participants	—	—
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Alkaline Phosphatase high, n=40	0 participants	—	—
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Alanine transaminase high, n=48	0 participants	—	—
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Total Bilirubin high, n=38	0 participants	—	—
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Sodium low, n=58	0 participants	—	—
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Sodium high, n=57	1 participants	—	—
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Calcium low, n=46	3 participants	—	—
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Phosphate low, n=43	0 participants	—	—
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Fasting Glucose low, n=39	0 participants	—	—
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Hemoglobin low, n= 63	0 participants	—	—
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry Uric Acid high, n=21	2 participants	—	—

SECONDARY outcome

Timeframe: Up to Week 26

Population: Safety population included all participants who received at least one dose of valganciclovir.

Cytomegalovirus (CMV) disease is defined as syndrome or tissue invasive disease in which CMV virus was identified in blood, urine, biopsy or other suitable specimen, which could be in conjunction with one or more of the following events: a) CMV syndrome was defined as virus present in blood or other suitable specimen, plus fever, and any of the following: leukopenia, atypical lymphocytosis, thrombopenia or elevated hepatic transaminases (for non-liver recipients). b) The diagnosis of organ specific tissue invasive CMV disease was evidence of CMV in the tissue (CMV inclusion bodies or in situ detection of CMV antigen or DNA), plus signs/symptoms of organ dysfunction.

Outcome measures

Measure	Valganciclovir Age Group <= 2 Years n=17 Participants Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years n=21 Participants Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years n=25 Participants Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Number of Participants With Cytomegalovirus Disease Over Time	0 participants	2 participants	2 participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: The Intent to Treat (ITT) population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.

Treatment failure was defined as either the development of CMV (viremia, antigenemia or test positive) requiring treatment up to day 100 post-transplant (i.e, while undergoing prophylaxis with valganciclovir up to day 100) or discontinuation of study medication due to lack of efficacy or to toxicity.

Outcome measures

Measure	Valganciclovir Age Group <= 2 Years n=17 Participants Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years n=21 Participants Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years n=25 Participants Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Number of Participants With Treatment Failures	2 participants	2 participants	0 participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: ITT population: The ITT population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.

Graft loss was defined as impairment of organ function to such a degree that the participant died or underwent re-transplantation.

Outcome measures

Measure	Valganciclovir Age Group <= 2 Years n=17 Participants Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years n=21 Participants Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years n=25 Participants Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Number of Participants Who Experienced Graft Loss Acute Graft Rejection	1 participants	0 participants	0 participants
Number of Participants Who Experienced Graft Loss Chronic Graft Rejection	0 participants	0 participants	0 participants
Number of Participants Who Experienced Graft Loss Recurrence of Underlying Disease	0 participants	0 participants	0 participants
Number of Participants Who Experienced Graft Loss Technical Complications	0 participants	0 participants	1 participants
Number of Participants Who Experienced Graft Loss Primary Graft Non-Function	0 participants	0 participants	0 participants
Number of Participants Who Experienced Graft Loss Other	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day (D) 7 to D 14; and at Week (W) 6, W 10, and W 14

Population: The PK analysis population comprised all participants from studies WP16296, WP16303 and WV16726 who completed the specified treatment and from whom at least one plasma sample was taken. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.

Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration of Valganciclovir. Participants with kidney, liver and heart transplant were analyzed. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.

Outcome measures

Measure	Valganciclovir Age Group <= 2 Years n=17 Participants Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years n=20 Participants Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years n=25 Participants Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Mean Maximum Plasma Concentration of Valganciclovir Over Time In kidney recipients, n=2, 12, 19	10 mcg/mL Standard Deviation 0.04	8.74 mcg/mL Standard Deviation 2.49	7.85 mcg/mL Standard Deviation 2.1
Mean Maximum Plasma Concentration of Valganciclovir Over Time In liver recipients, n=9, 6, 2	11.7 mcg/mL Standard Deviation 3.59	9.35 mcg/mL Standard Deviation 2.33	5.55 mcg/mL Standard Deviation 1.34
Mean Maximum Plasma Concentration of Valganciclovir Over Time In heart recipients, n=6, 2, 4	8.22 mcg/mL Standard Deviation 2.44	12.5 mcg/mL Standard Deviation 1.02	9.5 mcg/mL Standard Deviation 3.34

SECONDARY outcome

Timeframe: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14

Population: The PK analysis population comprised all participants from studies WP16296, WP16303 and WV16726 who completed the specified treatment and from whom at least one plasma sample was taken.

The Elimination Half-Life Period is defined as the time measured for the plasma concentration to decrease by half to its original concentration. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.

Outcome measures

Measure	Valganciclovir Age Group <= 2 Years n=17 Participants Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years n=20 Participants Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years n=25 Participants Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Mean Elimination Half-Life of Valganciclovir Over Time In liver recipients, n=9, 6, 2	2.72 hours Standard Deviation 1.32	3.61 hours Standard Deviation 0.8	4.5 hours Standard Deviation 0.25
Mean Elimination Half-Life of Valganciclovir Over Time In heart recipients, n=6, 2, 4	3.6 hours Standard Deviation 1.73	2.62 hours Standard Deviation 0.65	5.05 hours Standard Deviation 0.7
Mean Elimination Half-Life of Valganciclovir Over Time In kidney recipients, n=2, 12, 19	3.1 hours Standard Deviation 0.59	4.47 hours Standard Deviation 1.37	5.69 hours Standard Deviation 1.06

SECONDARY outcome

Timeframe: Up to Week 26

Population: The ITT population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.

Participants with biopsy proven active rejection are reported.

Outcome measures

Measure	Valganciclovir Age Group <= 2 Years n=17 Participants Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years n=21 Participants Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years n=25 Participants Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Number of Participants Who Experienced Episodes of Rejection Over Time	5 participants	2 participants	2 participants

Adverse Events

Valganciclovir Age Group <= 2 Years

Serious events: 13 serious events

Other events: 17 other events

Deaths: 0 deaths

Valganciclovir Age Group >2 to < 12 Years

Serious events: 11 serious events

Other events: 17 other events

Deaths: 0 deaths

Valganciclovir Age Group >= 12 Years

Serious events: 11 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Valganciclovir Age Group <= 2 Years n=17 participants at risk Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years n=21 participants at risk Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years n=25 participants at risk Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Vascular disorders Haematoma	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Vascular disorders Lymphocele	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Surgical and medical procedures Gastrostomy tube insertion	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmablastic lymphoma	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Immune system disorders Transplant rejection	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	12.0% 3/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
General disorders Pyrexia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
General disorders Chest pain	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
General disorders Influenza like illness	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Injury, poisoning and procedural complications Subdural haematoma	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Investigations Cytomegalovirus test positive	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Investigations Transaminases increased	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Investigations Blood creatinine increased	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Investigations Cytomegalovirus antigen positive	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Investigations Hepatic enzyme increased	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Cardiac disorders Cardiac failure	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Cardiac disorders Cardiac tamponade	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Blood and lymphatic system disorders Anaemia	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Blood and lymphatic system disorders Neutropenia	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Stridor	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Nervous system disorders Cerebral infarction	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Nervous system disorders Leukoencephalopathy	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Intra-abdominal haemorrhage	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Diarrhoea	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Gastrointestinal haemorrhage	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Gastrointestinal hypomotility	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Intestinal perforation	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Vomiting	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Hepatobiliary disorders Hepatic artery thrombosis	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Hepatobiliary disorders Bile duct stenosis	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Hepatobiliary disorders Cholangitis	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Hepatobiliary disorders Hepatic artery stenosis	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Hepatobiliary disorders Hepatic function abnormal	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Hepatobiliary disorders Portal vein thrombosis	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Renal and urinary disorders Renal failure acute	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Renal and urinary disorders Ureteric obstruction	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Metabolic disorder	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Cytomegalovirus Viraemia	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Epstein-barr virus infectionn	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Bacterial sepsis	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Biliary tract infection	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Ear infection	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Gastroenteritis	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Gastrointestinal infection	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Liver abscess	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Nasopharyngitis	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Pharyngitis	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Pyelonephritis	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Sepsis	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Upper respiratory tract infection	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Urinary tract infection	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Viral infection	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.

Other adverse events

Measure	Valganciclovir Age Group <= 2 Years n=17 participants at risk Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >2 to < 12 Years n=21 participants at risk Eligible participants aged \>2 to \< 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).	Valganciclovir Age Group >= 12 Years n=25 participants at risk Eligible participants aged \>= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 \* BSA \* CrCLS).
Infections and infestations Gastroenteritis	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Oral Candidiasis	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Pneumonia	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Respiratory Syncytial Virus Infection	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Respiratory Tract Infection	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Sepsis	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Abdominal Infection	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Candidiasis	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Central Line Infection	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Para Influenzae Virus Infection	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Feeding disorder	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Hyperphosphataemia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Hyperuricaemia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Hypoalbuminaemia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Hypoglycaemia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Upper Respiratory Tract	23.5% 4/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	23.8% 5/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	28.0% 7/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Nasopharyngitis	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	12.0% 3/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Urinary Tract Infection	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	16.0% 4/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Otitis Media	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	8.0% 2/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Cellulitis	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Clostridium Colitis	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Epstein-Barr Virus Infection	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Vascular disorders Hypertension	23.5% 4/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	28.6% 6/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	32.0% 8/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Vascular disorders Haematoma	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Immune system disorders Liver Transplant Rejection	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Immune system disorders Transplant Rejection	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Immune system disorders Milk Allergy	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
General disorders Pyrexia	29.4% 5/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	38.1% 8/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	16.0% 4/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
General disorders Oedema Peripheral	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	20.0% 5/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
General disorders Irritability	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
General disorders Catheter Site Discharge	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
General disorders Catheter Site Inflammation	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Psychiatric disorders Agitation	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	8.0% 2/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Psychiatric disorders Anxiety	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	8.0% 2/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Psychiatric disorders Insomnia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Injury, poisoning and procedural complications Incision site infection	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	16.0% 4/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Injury, poisoning and procedural complications Device Failure	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Injury, poisoning and procedural complications Graft Ischaemia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Injury, poisoning and procedural complications Postoperative Thoracic procedure complications	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Investigations Epstein-Barr Virus Test positive	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Investigations Blood Albumin Decreased	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Investigations White Blood Cell Count Increased	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Cardiac disorders Pericardial Effusion	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	8.0% 2/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Cardiac disorders Bradycardia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Cardiac disorders Cardiac Disorder	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Cardiac disorders Left Ventricular Failure	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Cardiac disorders Sinus Bradycardia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	23.8% 5/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	12.0% 3/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	16.0% 4/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Bronchospasm	17.6% 3/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Atelectasis	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	8.0% 2/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Wheezing	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Stridor	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Blood and lymphatic system disorders Anaemia	52.9% 9/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	19.0% 4/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Blood and lymphatic system disorders Neutropenia	23.5% 4/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Blood and lymphatic system disorders Leukocytosis	17.6% 3/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Blood and lymphatic system disorders Leukopenia	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	8.0% 2/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Blood and lymphatic system disorders Thrombocythaemia	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Blood and lymphatic system disorders Thrombocytopenia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Blood and lymphatic system disorders Lymphopenia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Nervous system disorders Headache	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	16.0% 4/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Nervous system disorders Convulsion	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Nervous system disorders Dystonia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Nervous system disorders Encephalomalacia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Diarrhoea	41.2% 7/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	38.1% 8/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	24.0% 6/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Vomiting	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	33.3% 7/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	28.0% 7/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Nausea	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	24.0% 6/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Constipation	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	23.8% 5/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	8.0% 2/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Abdominal pain	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	14.3% 3/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Abdominal Distention	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Ascites	17.6% 3/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Gastrointestinal Haemorrhage	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Teething	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Hepatobiliary disorders Biliary Tract Disorder	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Hepatobiliary disorders Hepatic Function Abnormal	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Renal and urinary disorders Haematuria	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	19.0% 4/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Renal and urinary disorders Dysuria	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	8.0% 2/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Renal and urinary disorders Acute Prerenal failure	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Renal and urinary disorders Renal Failure	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Pruritus	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	19.0% 4/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Rash	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	8.0% 2/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Acne	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	12.0% 3/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Dermatitis	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Dermatitis Diaper	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Hirsutism	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Pruritus Generalised	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Urticaria	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	12.0% 3/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Endocrine disorders Hypothyroidism	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Hypomagnesaemia	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	19.0% 4/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Hyperkalaemia	17.6% 3/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Hyperglycaemia	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.5% 2/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.0% 1/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Metabolic Acidosis	23.5% 4/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Hypokalaemia	11.8% 2/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.8% 1/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Pneumonia Bacterial	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Staphylococcal infection	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Stenotrophomonas infection	5.9% 1/17 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/21 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	0.00% 0/25 • Up to Week 26 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 61 6878333

Email: global.trial_information@roche.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER