Trial Outcomes & Findings for Long Term Study of Canakinumab (ACZ885) in Patients With Gout (NCT NCT00927810)

NCT ID: NCT00927810

Last Updated: 2021-07-02

Results Overview

Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 341 participants
• Primary outcome timeframe: From start of study up to study completion (up to 14 months)
• Results posted on: 2021-07-02

Participant Flow

The study was conducted at 75 centers in 18 countries.

A total of 341 participants enrolled in the study, out of which 330 participants completed the study.

Participant milestones

Measure	Core: Canakinumab, Extension: 150 mg Canakinumab Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Canakinumab, Extension: No Canakinumab Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: 150 mg Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]), received single SC dose of 150 mg Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: No Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]) and who did not receive canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).
Overall Study STARTED	75	181	25	60
Overall Study COMPLETED	75	173	24	58
Overall Study NOT COMPLETED	0	8	1	2

Reasons for withdrawal

Measure	Core: Canakinumab, Extension: 150 mg Canakinumab Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Canakinumab, Extension: No Canakinumab Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: 150 mg Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]), received single SC dose of 150 mg Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: No Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]) and who did not receive canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).
Overall Study Withdrawal by Subject	0	3	0	1
Overall Study Lost to Follow-up	0	2	1	1
Overall Study Death	0	2	0	0
Overall Study Abnormal laboratory value(s)	0	1	0	0

Baseline Characteristics

Long Term Study of Canakinumab (ACZ885) in Patients With Gout

Baseline characteristics by cohort

Measure	Core: Canakinumab, Extension: 150 mg Canakinumab n=75 Participants Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Canakinumab, Extension: No Canakinumab n=181 Participants Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: 150 mg Canakinumab n=25 Participants Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: No Canakinumab n=60 Participants Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Total n=341 Participants Total of all reporting groups
Age, Continuous	50.7 years STANDARD_DEVIATION 10.20 • n=5 Participants	53.8 years STANDARD_DEVIATION 11.39 • n=7 Participants	52.0 years STANDARD_DEVIATION 11.00 • n=5 Participants	51.5 years STANDARD_DEVIATION 9.45 • n=4 Participants	52.6 years STANDARD_DEVIATION 10.83 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	13 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants	22 Participants n=21 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	168 Participants n=7 Participants	25 Participants n=5 Participants	53 Participants n=4 Participants	319 Participants n=21 Participants
Race/Ethnicity, Customized Caucasian	46 Participants n=5 Participants	143 Participants n=7 Participants	19 Participants n=5 Participants	49 Participants n=4 Participants	257 Participants n=21 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants
Race/Ethnicity, Customized Asian	11 Participants n=5 Participants	10 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	25 Participants n=21 Participants
Race/Ethnicity, Customized Native American	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized Pacific islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Other	15 Participants n=5 Participants	19 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	42 Participants n=21 Participants

PRIMARY outcome

Timeframe: From start of study up to study completion (up to 14 months)

Population: Safety Set 1 consisted of all participants from the core study who entered the extension study.

Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards

Outcome measures

Measure	Core: Canakinumab, Extension: 150 mg Canakinumab n=75 Participants Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Canakinumab, Extension: No Canakinumab n=181 Participants Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: 150 mg Canakinumab n=25 Participants Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: No Canakinumab n=60 Participants Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).
Number of Participants With Adverse Events and Serious Adverse Events	31 Participants	52 Participants	9 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline and Day 7

Population: Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]. Here the number of participants analyzed signifies participants who were evaluable for this measure.

Gout pain was assessed using Visual analogue scale (VAS) with a range of 0 to 100 where 0= no pain, 100= unbearable pain. Difference from time of study drug administration (pre-dose) was reported.

Outcome measures

Measure	Core: Canakinumab, Extension: 150 mg Canakinumab n=52 Participants Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Canakinumab, Extension: No Canakinumab n=13 Participants Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: 150 mg Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: No Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).
Difference Change From Baseline in Participant's Gout Pain During First Flare	-51.7 units on a scale Standard Deviation 15.86	-67.4 units on a scale Standard Deviation 21.69	—	—

SECONDARY outcome

Timeframe: 24 weeks

Population: Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]. Here the number of participants analyzed signifies participants who were evaluable for this measure.

Patient's global assessment of response to treatment is 5-point Likert scale:1.Excellent, 2.Good, 3.Acceptable, 4.Slight, 5.Poor. Lower the score better the outcome.

Outcome measures

Measure	Core: Canakinumab, Extension: 150 mg Canakinumab n=63 Participants Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Canakinumab, Extension: No Canakinumab n=21 Participants Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: 150 mg Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: No Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 1. Gout Flare: Excellent	40 Participants	7 Participants	—	—
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 1. Gout Flare: Good	17 Participants	14 Participants	—	—
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 1. Gout Flare: Acceptable	5 Participants	0 Participants	—	—
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 1. Gout Flare: Slight	1 Participants	0 Participants	—	—
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 1. Gout Flare: Poor	0 Participants	0 Participants	—	—
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 2. Gout Flare: Excellent	4 Participants	4 Participants	—	—
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 2. Gout Flare: Good	6 Participants	1 Participants	—	—
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 2. Gout Flare: Acceptable	1 Participants	0 Participants	—	—
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 2. Gout Flare: Slight	0 Participants	0 Participants	—	—
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 2. Gout Flare: Poor	0 Participants	0 Participants	—	—
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 3. Gout Flare: Excellent	2 Participants	0 Participants	—	—
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 3. Gout Flare: Good	1 Participants	1 Participants	—	—
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 3. Gout Flare: Acceptable	0 Participants	0 Participants	—	—
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 3. Gout Flare: Slight	0 Participants	0 Participants	—	—
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 3. Gout Flare: Poor	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: 24 weeks

Population: Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]. Here the number of participants analyzed signifies participants who were evaluable for this measure.

Physician's global assessment of response to treatment is 5-point Likert scale:1.Very good, 2.Good, 3.Fair, 4.Poor, 5.Very poor. Lower the score better the outcome.

Outcome measures

Measure	Core: Canakinumab, Extension: 150 mg Canakinumab n=69 Participants Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Canakinumab, Extension: No Canakinumab n=23 Participants Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: 150 mg Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: No Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 1. Gout Flare: Very Good	37 Participants	13 Participants	—	—
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 1. Gout Flare: Good	28 Participants	10 Participants	—	—
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 1. Gout Flare: Fair	2 Participants	0 Participants	—	—
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 1. Gout Flare: Poor	2 Participants	0 Participants	—	—
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 1. Gout Flare: Very Poor	0 Participants	0 Participants	—	—
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 2. Gout Flare: Very good	5 Participants	3 Participants	—	—
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 2. Gout Flare: Good	7 Participants	2 Participants	—	—
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 2. Gout Flare: Fair	0 Participants	0 Participants	—	—
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 2. Gout Flare: Poor	0 Participants	0 Participants	—	—
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 2. Gout Flare: Very poor	0 Participants	0 Participants	—	—
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 3. Gout Flare: Very Good	1 Participants	0 Participants	—	—
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 3. Gout Flare: Good	2 Participants	1 Participants	—	—
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 3. Gout Flare: Fair	0 Participants	0 Participants	—	—
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 3. Gout Flare: Poor	0 Participants	0 Participants	—	—
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category 3. Gout Flare: Very poor	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: 24 weeks

Population: Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]. Here the number of participants analyzed signifies participants who were evaluable for this measure.

Tenderness was rated on a 0-3 point scale: 0="no pain", 1=patient states that "there is pain", 2=patient states "there is pain and winces", and 3=patient states "there is pain, winces and withdraws" on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0="no swelling", 1="palpable", 2="visible", and 3=bulging beyond the joint margins". Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits.

Outcome measures

Measure	Core: Canakinumab, Extension: 150 mg Canakinumab n=69 Participants Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Canakinumab, Extension: No Canakinumab n=24 Participants Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: 150 mg Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: No Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).
Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group Tenderness-Flare Visit- No pain	2 Participants	0 Participants	—	—
Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group Tenderness-Control Visit- No pain	60 Participants	21 Participants	—	—
Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group Joint swelling-Flare Visit-No swelling	5 Participants	0 Participants	—	—
Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group Joint swelling-Control Visit-No swelling	61 Participants	22 Participants	—	—
Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group Erythema-Flare Visit-Absent	21 Participants	4 Participants	—	—
Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group Erythema-Control Visit-Absent	66 Participants	24 Participants	—	—

SECONDARY outcome

Timeframe: 24 weeks

Population: Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]. Here the number of participants analyzed signifies participants who were evaluable for this measure.

The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.

Outcome measures

Measure	Core: Canakinumab, Extension: 150 mg Canakinumab n=68 Participants Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Canakinumab, Extension: No Canakinumab n=24 Participants Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: 150 mg Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: No Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).
Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group 2.Gout flare-Prednisolone	1.3 milligrams (mg) Standard Deviation 3.11	0.0 milligrams (mg) Standard Deviation 0.00	—	—
Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group 3.Gout flare-Naproxen	250.0 milligrams (mg) Standard Deviation 500.00	0.0 milligrams (mg) Standard Deviation 0	—	—
Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group 3.Gout flare-Prednisolone	0.0 milligrams (mg) Standard Deviation 0.00	0.0 milligrams (mg) Standard Deviation 0	—	—
Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group 1.Gout flare-Naproxen	1086.8 milligrams (mg) Standard Deviation 1592.72	954.6 milligrams (mg) Standard Deviation 1130.19	—	—
Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group 1.Gout flare-Prednisolone	4.6 milligrams (mg) Standard Deviation 20.84	4.2 milligrams (mg) Standard Deviation 20.41	—	—
Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group 2.Gout flare-Naproxen	650.0 milligrams (mg) Standard Deviation 642.79	200.0 milligrams (mg) Standard Deviation 447.21	—	—

Adverse Events

Core: Canakinumab 25 mg

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Core: Canakinumab 50 mg

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Core: Canakinumab 100 mg

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Core: Canakinumab 200 mg

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Core: Canakinumab 300 mg

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Core : Canakinumab Q4wk mg

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Core : Colchicine 0.5 mg

Serious events: 6 serious events

Other events: 21 other events

Deaths: 1 deaths

Core: Canakinumab, Extension: 150 mg Canakinumab

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

Core: Canakinumab, Extension: No Canakinumab

Serious events: 6 serious events

Other events: 19 other events

Deaths: 2 deaths

Core: Colchicine, Extension: 150 mg Canakinumab

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Core: Colchicine, Extension: No Canakinumab

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Core: Canakinumab 25 mg n=55 participants at risk Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.	Core: Canakinumab 50 mg n=54 participants at risk Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.	Core: Canakinumab 100 mg n=54 participants at risk Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.	Core: Canakinumab 200 mg n=54 participants at risk Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.	Core: Canakinumab 300 mg n=53 participants at risk Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.	Core : Canakinumab Q4wk mg n=53 participants at risk Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.	Core : Colchicine 0.5 mg n=108 participants at risk Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.	Core: Canakinumab, Extension: 150 mg Canakinumab n=75 participants at risk Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Canakinumab, Extension: No Canakinumab n=181 participants at risk Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: 150 mg Canakinumab n=25 participants at risk Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: No Canakinumab n=60 participants at risk Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).
Cardiac disorders Acute myocardial infarction	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Cardiac disorders Angina pectoris	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Cardiac disorders Myocardial fibrosis	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.55% 1/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Cardiac disorders Myocardial infarction	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Gastrointestinal disorders Abdominal hernia	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.55% 1/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Gastrointestinal disorders Abdominal pain	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Gastrointestinal disorders Colitis ulcerative	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Gastrointestinal disorders Gastritis	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/55 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Gastrointestinal disorders Inguinal hernia	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	1.3% 1/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Gastrointestinal disorders Umbilical hernia	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Hepatobiliary disorders Cholelithiasis	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Infections and infestations Diverticulitis	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	1.3% 1/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Infections and infestations Ear infection	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	1.9% 1/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Infections and infestations Erysipelas	1.8% 1/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Infections and infestations Gangrene	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Infections and infestations Pneumonia	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	1.9% 1/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Infections and infestations Sepsis	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Infections and infestations Tonsillitis	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Injury, poisoning and procedural complications Femur fracture	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.55% 1/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Injury, poisoning and procedural complications Hand fracture	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Injury, poisoning and procedural complications Heat exhaustion	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.55% 1/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.55% 1/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	1.7% 1/60 • From start of study up to study completion (up to 14 months)
Injury, poisoning and procedural complications Radius fracture	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Injury, poisoning and procedural complications Tibia fracture	1.8% 1/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Musculoskeletal and connective tissue disorders Gouty tophus	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	1.3% 1/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Nervous system disorders Stupor	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Nervous system disorders Transient ischaemic attack	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.55% 1/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Renal and urinary disorders Haematuria	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Renal and urinary disorders Nephrolithiasis	0.00% 0/55 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Renal and urinary disorders Nephrotic syndrome	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Renal and urinary disorders Renal failure	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Reproductive system and breast disorders Prostatitis	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	1.3% 1/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Vascular disorders Deep vein thrombosis	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	1.3% 1/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)

Other adverse events

Measure	Core: Canakinumab 25 mg n=55 participants at risk Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.	Core: Canakinumab 50 mg n=54 participants at risk Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.	Core: Canakinumab 100 mg n=54 participants at risk Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.	Core: Canakinumab 200 mg n=54 participants at risk Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.	Core: Canakinumab 300 mg n=53 participants at risk Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.	Core : Canakinumab Q4wk mg n=53 participants at risk Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.	Core : Colchicine 0.5 mg n=108 participants at risk Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.	Core: Canakinumab, Extension: 150 mg Canakinumab n=75 participants at risk Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Canakinumab, Extension: No Canakinumab n=181 participants at risk Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: 150 mg Canakinumab n=25 participants at risk Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]).	Core: Colchicine, Extension: No Canakinumab n=60 participants at risk Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]).
Gastrointestinal disorders Diarrhoea	5.5% 3/55 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	3.7% 2/54 • From start of study up to study completion (up to 14 months)	5.6% 3/54 • From start of study up to study completion (up to 14 months)	1.9% 1/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	1.9% 2/108 • From start of study up to study completion (up to 14 months)	2.7% 2/75 • From start of study up to study completion (up to 14 months)	0.55% 1/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Gastrointestinal disorders Nausea	3.6% 2/55 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	5.6% 3/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	1.9% 1/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.55% 1/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Infections and infestations Nasopharyngitis	9.1% 5/55 • From start of study up to study completion (up to 14 months)	3.7% 2/54 • From start of study up to study completion (up to 14 months)	3.7% 2/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	5.7% 3/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.55% 1/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	3.3% 2/60 • From start of study up to study completion (up to 14 months)
Infections and infestations Upper respiratory tract infection	3.6% 2/55 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	3.7% 2/54 • From start of study up to study completion (up to 14 months)	5.6% 3/54 • From start of study up to study completion (up to 14 months)	1.9% 1/53 • From start of study up to study completion (up to 14 months)	5.7% 3/53 • From start of study up to study completion (up to 14 months)	3.7% 4/108 • From start of study up to study completion (up to 14 months)	6.7% 5/75 • From start of study up to study completion (up to 14 months)	2.2% 4/181 • From start of study up to study completion (up to 14 months)	4.0% 1/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Investigations Alanine aminotransferase increased	5.5% 3/55 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Investigations Aspartate aminotransferase increased	5.5% 3/55 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.55% 1/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	3.7% 2/54 • From start of study up to study completion (up to 14 months)	1.9% 1/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.55% 1/181 • From start of study up to study completion (up to 14 months)	8.0% 2/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Musculoskeletal and connective tissue disorders Arthralgia	7.3% 4/55 • From start of study up to study completion (up to 14 months)	9.3% 5/54 • From start of study up to study completion (up to 14 months)	7.4% 4/54 • From start of study up to study completion (up to 14 months)	3.7% 2/54 • From start of study up to study completion (up to 14 months)	5.7% 3/53 • From start of study up to study completion (up to 14 months)	3.8% 2/53 • From start of study up to study completion (up to 14 months)	2.8% 3/108 • From start of study up to study completion (up to 14 months)	5.3% 4/75 • From start of study up to study completion (up to 14 months)	3.3% 6/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	1.7% 1/60 • From start of study up to study completion (up to 14 months)
Musculoskeletal and connective tissue disorders Back pain	5.5% 3/55 • From start of study up to study completion (up to 14 months)	5.6% 3/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	5.6% 3/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	3.7% 4/108 • From start of study up to study completion (up to 14 months)	1.3% 1/75 • From start of study up to study completion (up to 14 months)	1.1% 2/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Nervous system disorders Headache	7.3% 4/55 • From start of study up to study completion (up to 14 months)	5.6% 3/54 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	3.7% 2/54 • From start of study up to study completion (up to 14 months)	11.3% 6/53 • From start of study up to study completion (up to 14 months)	5.7% 3/53 • From start of study up to study completion (up to 14 months)	5.6% 6/108 • From start of study up to study completion (up to 14 months)	4.0% 3/75 • From start of study up to study completion (up to 14 months)	1.1% 2/181 • From start of study up to study completion (up to 14 months)	4.0% 1/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/55 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	3.7% 2/54 • From start of study up to study completion (up to 14 months)	3.7% 2/54 • From start of study up to study completion (up to 14 months)	1.9% 1/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.00% 0/108 • From start of study up to study completion (up to 14 months)	5.3% 4/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/55 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	5.7% 3/53 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	0.00% 0/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)
Skin and subcutaneous tissue disorders Rash	1.8% 1/55 • From start of study up to study completion (up to 14 months)	1.9% 1/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/54 • From start of study up to study completion (up to 14 months)	0.00% 0/53 • From start of study up to study completion (up to 14 months)	5.7% 3/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	1.3% 1/75 • From start of study up to study completion (up to 14 months)	0.00% 0/181 • From start of study up to study completion (up to 14 months)	0.00% 0/25 • From start of study up to study completion (up to 14 months)	1.7% 1/60 • From start of study up to study completion (up to 14 months)
Vascular disorders Hypertension	10.9% 6/55 • From start of study up to study completion (up to 14 months)	3.7% 2/54 • From start of study up to study completion (up to 14 months)	3.7% 2/54 • From start of study up to study completion (up to 14 months)	9.3% 5/54 • From start of study up to study completion (up to 14 months)	7.5% 4/53 • From start of study up to study completion (up to 14 months)	3.8% 2/53 • From start of study up to study completion (up to 14 months)	0.93% 1/108 • From start of study up to study completion (up to 14 months)	8.0% 6/75 • From start of study up to study completion (up to 14 months)	1.7% 3/181 • From start of study up to study completion (up to 14 months)	8.0% 2/25 • From start of study up to study completion (up to 14 months)	0.00% 0/60 • From start of study up to study completion (up to 14 months)

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: +1 (862) 778-8300

Email: novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER