Trial Outcomes & Findings for Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome (NCT NCT00230178)

NCT ID: NCT00230178

Last Updated: 2010-01-12

Results Overview

Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 \<7.5 mg/dl.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

280 participants

Primary outcome timeframe

Day 3 through Day 7

Results posted on

2010-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	Rasburicase Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days	Rasburicase + Allopurinol Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)	Allopurinol Allopurinol (300 mg/day) given alone as a single agent for 5 days
Overall Study STARTED	94	93	93
Overall Study Treated	92	92	91
Overall Study COMPLETED	90	86	86
Overall Study NOT COMPLETED	4	7	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Rasburicase Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days	Rasburicase + Allopurinol Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)	Allopurinol Allopurinol (300 mg/day) given alone as a single agent for 5 days
Overall Study Adverse Event	1	5	2
Overall Study Withdrawal by Subject	0	0	1
Overall Study Various other reasons	3	2	4

Baseline Characteristics

Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rasburicase n=94 Participants Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days	Rasburicase + Allopurinol n=93 Participants Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)	Allopurinol n=93 Participants Allopurinol (300 mg/day) given alone as a single agent for 5 days	Total n=280 Participants Total of all reporting groups
Age, Customized <65 years	63 participants n=5 Participants	65 participants n=7 Participants	69 participants n=5 Participants	197.0 participants n=4 Participants
Age, Customized >=65 years	31 participants n=5 Participants	28 participants n=7 Participants	24 participants n=5 Participants	83.0 participants n=4 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	42 Participants n=7 Participants	29 Participants n=5 Participants	106.0 Participants n=4 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	51 Participants n=7 Participants	64 Participants n=5 Participants	174.0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 3 through Day 7

Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 \<7.5 mg/dl.

Outcome measures

Outcome measures
Measure	Rasburicase n=92 Participants Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days	Rasburicase + Allopurinol n=92 Participants Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)	Allopurinol n=91 Participants Allopurinol (300 mg/day) given alone as a single agent for 5 days
Plasma Uric Acid Responder Responder	80 Participants	72 Participants	60 Participants
Plasma Uric Acid Responder Non-Responder	12 Participants	20 Participants	31 Participants

SECONDARY outcome

Timeframe: Day 1 to Day 7

Population: The analysis was performed on the modified ITT-population with an evaluation of plasma uric acid AUC.

Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values

Outcome measures

Outcome measures
Measure	Rasburicase n=80 Participants Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days	Rasburicase + Allopurinol n=77 Participants Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)	Allopurinol n=72 Participants Allopurinol (300 mg/day) given alone as a single agent for 5 days
Plasma Uric Acid	77.25 mg*h/dL Standard Deviation 57.17	108.05 mg*h/dL Standard Deviation 70.49	646.22 mg*h/dL Standard Deviation 285.29

SECONDARY outcome

Timeframe: Day 1 to Day 7

Population: The analysis was performed on a subgroup of patients from the mITT-population with hyperuricemia immediately prior to the first dose of study drug.

Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined \<=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion.

Outcome measures

Outcome measures
Measure	Rasburicase n=18 Participants Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days	Rasburicase + Allopurinol n=12 Participants Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)	Allopurinol n=16 Participants Allopurinol (300 mg/day) given alone as a single agent for 5 days
Time to Uric Acid Control	4.1 Hours Interval 4.0 to 4.5	4.1 Hours Interval 3.9 to 4.5	27.0 Hours Interval 4.0 to 49.0

Adverse Events

Rasburicase

Serious events: 36 serious events

Other events: 91 other events

Deaths: 0 deaths

Rasburicase + Allopurinol

Serious events: 32 serious events

Other events: 92 other events

Deaths: 0 deaths

Allopurinol

Serious events: 29 serious events

Other events: 90 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

International Clinical Development, Clinical Study Director

Sanofi-aventis

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Rasburicase n=92 participants at risk Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days	Rasburicase + Allopurinol n=92 participants at risk Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)	Allopurinol n=91 participants at risk Allopurinol (300 mg/day) given alone as a single agent for 5 days
Blood and lymphatic system disorders Febrile neutropenia	4.3% 4/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	3.3% 3/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	5.5% 5/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Blood and lymphatic system disorders Thrombocytopenia	2.2% 2/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Blood and lymphatic system disorders Neutropenia	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Blood and lymphatic system disorders Pancytopenia	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Cardiac disorders Atrial fibrillation	2.2% 2/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Cardiac disorders Cardio-respiratory arrest	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Cardiac disorders Acute myocardial infarction	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Cardiac disorders Angina pectoris	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Cardiac disorders Myocardial infarction	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Cardiac disorders Pericardial effusion	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Cardiac disorders Tachycardia	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Cardiac disorders Supraventricular tachycardia	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Abdominal pain	2.2% 2/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Haemorrhoids	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Proctalgia	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Rectal haemorrhage	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Small intestinal obstruction	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Constipation	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Diarrhoea	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Peritonitis	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Colitis	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Multi-organ failure	2.2% 2/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	2.2% 2/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	2.2% 2/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Pyrexia	2.2% 2/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Adverse drug reaction	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Disease progression	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Death	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Hepatobiliary disorders Cholelithiasis	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Hepatobiliary disorders Hyperbilirubinaemia	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Hepatobiliary disorders Hepatic failure	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Immune system disorders Hypersensitivity	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Immune system disorders Drug hypersensitivity	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Infections and infestations Neutropenic infection	5.4% 5/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	4.3% 4/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	8.8% 8/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Infections and infestations Neutropenic sepsis	5.4% 5/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	3.3% 3/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Infections and infestations Sepsis	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Infections and infestations Infection	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Infections and infestations Lung infection	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Infections and infestations Septic shock	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.

Other adverse events
Measure	Rasburicase n=92 participants at risk Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days	Rasburicase + Allopurinol n=92 participants at risk Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)	Allopurinol n=91 participants at risk Allopurinol (300 mg/day) given alone as a single agent for 5 days
Blood and lymphatic system disorders Thrombocytopenia	55.4% 51/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	53.3% 49/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	52.7% 48/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Blood and lymphatic system disorders Neutropenia	53.3% 49/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	47.8% 44/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	49.5% 45/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Blood and lymphatic system disorders Anaemia	33.7% 31/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	33.7% 31/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	47.3% 43/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Blood and lymphatic system disorders Febrile neutropenia	20.7% 19/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	23.9% 22/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	23.1% 21/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Blood and lymphatic system disorders Leukopenia	16.3% 15/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	13.0% 12/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	12.1% 11/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Blood and lymphatic system disorders Lymphopenia	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	5.4% 5/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Cardiac disorders Tachycardia	21.7% 20/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	25.0% 23/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	24.2% 22/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Cardiac disorders Atrial fibrillation	6.5% 6/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	3.3% 3/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	3.3% 3/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Cardiac disorders Angina pectoris	5.4% 5/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	4.3% 4/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Cardiac disorders Bradycardia	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	6.5% 6/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	4.4% 4/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Ear and labyrinth disorders Ear and labyrinth disorder	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	7.6% 7/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	5.5% 5/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Eye disorders Dry eye	0.00% 0/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	5.4% 5/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	0.00% 0/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Nausea	57.6% 53/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	60.9% 56/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	54.9% 50/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Diarrhoea	56.5% 52/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	56.5% 52/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	56.0% 51/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Vomiting	38.0% 35/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	37.0% 34/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	30.8% 28/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Constipation	27.2% 25/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	27.2% 25/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	34.1% 31/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Abdominal pain	19.6% 18/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	33.7% 31/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	24.2% 22/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Abdominal pain upper	10.9% 10/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	6.5% 6/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	17.6% 16/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Dyspepsia	9.8% 9/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	7.6% 7/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	13.2% 12/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Abdominal distension	8.7% 8/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	8.7% 8/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	13.2% 12/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Haemorrhoids	8.7% 8/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	4.3% 4/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	3.3% 3/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Flatulence	6.5% 6/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	8.7% 8/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	7.7% 7/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Proctalgia	4.3% 4/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	5.4% 5/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	5.5% 5/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Oral pain	4.3% 4/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	4.3% 4/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	8.8% 8/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Stomatitis	3.3% 3/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	6.5% 6/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	7.7% 7/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Dysphagia	3.3% 3/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	6.5% 6/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Rectal haemorrhage	3.3% 3/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	3.3% 3/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	5.5% 5/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Abdominal discomfort	2.2% 2/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	5.4% 5/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	7.7% 7/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
Gastrointestinal disorders Dry mouth	2.2% 2/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	5.4% 5/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	7.7% 7/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Oedema peripheral	50.0% 46/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	43.5% 40/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	42.9% 39/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Pyrexia	47.8% 44/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	60.9% 56/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	56.0% 51/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Chills	28.3% 26/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	35.9% 33/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	36.3% 33/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Mucosal inflammation	25.0% 23/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	27.2% 25/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	26.4% 24/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Fatigue	20.7% 19/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	30.4% 28/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	37.4% 34/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Asthenia	13.0% 12/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	13.0% 12/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	20.9% 19/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Catheter site pain	9.8% 9/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	4.3% 4/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	8.8% 8/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Pain	8.7% 8/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	10.9% 10/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	7.7% 7/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Oedema	6.5% 6/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	2.2% 2/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	6.6% 6/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Catheter site related reaction	5.4% 5/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	2.2% 2/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	4.4% 4/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.
General disorders Catheter site erythema	5.4% 5/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	1.1% 1/92 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.	8.8% 8/91 • Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment. Reported events are treatment emergent adverse events within the time frame mentioned above.